e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
Quarterly Report Under Section 13 or 15(d) of the
Securities Exchange Act of 1934
FOR THE QUARTER ENDED JUNE 30, 2006
COMMISSION FILE NUMBER 001-6351
ELI LILLY AND COMPANY
(Exact name of Registrant as specified in its charter)
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INDIANA
(State or other jurisdiction of
incorporation or organization)
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35-0470950
(I.R.S. Employer
Identification No.) |
LILLY CORPORATE CENTER, INDIANAPOLIS, INDIANA 46285
(Address of principal executive offices)
Registrants telephone number, including area code (317) 276-2000
Indicate by check mark whether the Registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months and (2) has been subject to such filing requirements for the
past 90 days.
Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer.
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of shares of common stock outstanding as of July 20, 2006:
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Class |
|
Number of Shares Outstanding |
Common
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|
1,130,398,796 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED CONDENSED STATEMENTS OF INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2006 |
|
2005 |
|
2006 |
|
2005 |
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|
(Dollars in millions, except per-share data) |
Net sales |
|
$ |
3,866.9 |
|
|
$ |
3,667.7 |
|
|
$ |
7,581.6 |
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|
$ |
7,165.1 |
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|
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|
|
|
|
|
|
|
|
|
|
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|
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Cost of sales |
|
|
860.6 |
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|
|
871.3 |
|
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|
1,667.1 |
|
|
|
1,730.3 |
|
Research and development |
|
|
774.8 |
|
|
|
762.4 |
|
|
|
1,515.6 |
|
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|
1,464.6 |
|
Marketing and administrative |
|
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1,237.9 |
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|
1,146.1 |
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2,380.8 |
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|
2,236.5 |
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Asset impairments, restructuring, and other special charges |
|
|
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|
|
|
1,073.4 |
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|
1,073.4 |
|
Other income net |
|
|
(46.9 |
) |
|
|
(45.4 |
) |
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|
(79.1 |
) |
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(144.0 |
) |
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2,826.4 |
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|
3,807.8 |
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5,484.4 |
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6,360.8 |
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Income (loss) before income taxes |
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|
1,040.5 |
|
|
|
(140.1 |
) |
|
|
2,097.2 |
|
|
|
804.3 |
|
Income taxes |
|
|
218.5 |
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|
|
111.9 |
|
|
|
440.4 |
|
|
|
319.7 |
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|
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Net income (loss) |
|
$ |
822.0 |
|
|
$ |
(252.0 |
) |
|
$ |
1,656.8 |
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$ |
484.6 |
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Earnings (loss) per share basic |
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$ |
.76 |
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$ |
(.23 |
) |
|
$ |
1.53 |
|
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$ |
.45 |
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|
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|
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Earnings (loss) per share diluted |
|
$ |
.76 |
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|
$ |
(.23 |
) |
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$ |
1.53 |
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$ |
.44 |
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Dividends paid per share |
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$ |
.40 |
|
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$ |
.38 |
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$ |
.80 |
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$ |
.76 |
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|
See Notes to Consolidated Condensed Financial Statements.
2
CONSOLIDATED CONDENSED BALANCE SHEETS
Eli Lilly and Company and Subsidiaries
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June 30, |
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December 31, |
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2006 |
|
2005 |
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(Dollars in millions) |
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(Unaudited) |
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|
ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
|
$ |
2,669.7 |
|
|
$ |
3,006.7 |
|
Short-term investments |
|
|
1,921.0 |
|
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|
2,031.0 |
|
Accounts receivable, net of allowances
of $64.9 (2006) and $66.3 (2005) |
|
|
2,101.8 |
|
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|
2,313.3 |
|
Other receivables |
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|
415.0 |
|
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|
448.4 |
|
Inventories |
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2,099.2 |
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1,878.0 |
|
Deferred income taxes |
|
|
648.9 |
|
|
|
756.4 |
|
Prepaid expenses |
|
|
733.0 |
|
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|
362.0 |
|
|
|
|
TOTAL CURRENT ASSETS |
|
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10,588.6 |
|
|
|
10,795.8 |
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|
OTHER ASSETS |
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|
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Prepaid pension |
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2,360.8 |
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2,419.6 |
|
Investments |
|
|
1,287.8 |
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1,296.6 |
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Sundry |
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2,110.4 |
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2,156.3 |
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|
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5,759.0 |
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5,872.5 |
|
PROPERTY AND EQUIPMENT |
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Land, buildings, equipment, and construction-in-progress |
|
|
13,568.1 |
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13,136.0 |
|
Less allowances for depreciation |
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(5,480.1 |
) |
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(5,223.5 |
) |
|
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8,088.0 |
|
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|
7,912.5 |
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$ |
24,435.6 |
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|
$ |
24,580.8 |
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|
LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
|
|
|
|
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Short-term borrowings |
|
$ |
738.6 |
|
|
$ |
734.7 |
|
Accounts payable |
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648.9 |
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|
781.3 |
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Employee compensation |
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|
374.1 |
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|
548.8 |
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Dividends payable |
|
|
438.3 |
|
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|
436.5 |
|
Income taxes payable |
|
|
700.9 |
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|
884.9 |
|
Other current liabilities |
|
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1,744.5 |
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|
2,330.1 |
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|
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TOTAL CURRENT LIABILITIES |
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4,645.3 |
|
|
|
5,716.3 |
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LONG-TERM DEBT |
|
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5,578.0 |
|
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|
5,763.5 |
|
DEFERRED INCOME TAXES |
|
|
759.4 |
|
|
|
695.1 |
|
OTHER NONCURRENT LIABILITIES |
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1,524.4 |
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1,614.0 |
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SHAREHOLDERS EQUITY |
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Common stock |
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707.0 |
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|
706.9 |
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Additional paid-in capital |
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3,365.2 |
|
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|
3,323.8 |
|
Retained earnings |
|
|
10,817.6 |
|
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|
10,027.2 |
|
Employee benefit trust |
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(2,635.0 |
) |
|
|
(2,635.0 |
) |
Deferred costs-ESOP |
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|
(103.7 |
) |
|
|
(106.3 |
) |
Accumulated other comprehensive loss |
|
|
(120.0 |
) |
|
|
(420.6 |
) |
|
|
|
|
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|
12,031.1 |
|
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|
10,896.0 |
|
Less cost of common stock in treasury |
|
|
102.6 |
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|
104.1 |
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|
|
|
|
|
11,928.5 |
|
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|
10,791.9 |
|
|
|
|
|
|
$ |
24,435.6 |
|
|
$ |
24,580.8 |
|
|
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|
See Notes to Consolidated Condensed Financial Statements.
3
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Six Months Ended June 30, |
|
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2006 |
|
2005 |
|
|
(Dollars in millions) |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,656.8 |
|
|
$ |
484.6 |
|
Adjustments to reconcile net income to cash flows from
operating activities: |
|
|
|
|
|
|
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|
Changes in operating assets and liabilities |
|
|
(1,357.3 |
) |
|
|
(369.0 |
) |
Depreciation and amortization |
|
|
414.0 |
|
|
|
317.4 |
|
Stock-based compensation expense |
|
|
191.3 |
|
|
|
208.2 |
|
Change in deferred taxes |
|
|
120.7 |
|
|
|
(175.9 |
) |
Asset impairments, restructuring, and other special charges,
net of tax |
|
|
|
|
|
|
979.7 |
|
Other, net |
|
|
(83.3 |
) |
|
|
33.9 |
|
|
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|
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|
NET CASH PROVIDED BY OPERATING ACTIVITIES |
|
|
942.2 |
|
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|
1,478.9 |
|
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CASH FLOWS FROM INVESTING ACTIVITIES |
|
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|
|
|
|
|
|
Net purchases of property and equipment |
|
|
(392.1 |
) |
|
|
(619.9 |
) |
Net change in short-term investments |
|
|
103.9 |
|
|
|
1,337.8 |
|
Purchase of noncurrent investments |
|
|
(1,003.2 |
) |
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|
(218.1 |
) |
Proceeds from sales and maturities of noncurrent investments |
|
|
906.2 |
|
|
|
270.8 |
|
Other, net |
|
|
126.9 |
|
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|
(145.1 |
) |
|
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|
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|
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES |
|
|
(258.3 |
) |
|
|
625.5 |
|
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CASH FLOWS FROM FINANCING ACTIVITIES |
|
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|
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|
Dividends paid |
|
|
(864.6 |
) |
|
|
(821.2 |
) |
Purchases of common stock |
|
|
(122.1 |
) |
|
|
|
|
Repayment of long-term debt |
|
|
(100.1 |
) |
|
|
(94.0 |
) |
Issuances of common stock under stock plans |
|
|
13.9 |
|
|
|
34.9 |
|
Net change in short-term borrowings |
|
|
4.9 |
|
|
|
(1,791.9 |
) |
Other, net |
|
|
.2 |
|
|
|
7.9 |
|
|
|
|
|
|
|
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|
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NET CASH USED IN FINANCING ACTIVITIES |
|
|
(1,067.8 |
) |
|
|
(2,664.3 |
) |
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
46.9 |
|
|
|
(163.0 |
) |
|
|
|
|
|
|
|
|
|
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
|
|
(337.0 |
) |
|
|
(722.9 |
) |
|
|
|
|
|
|
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|
Cash and cash equivalents at January 1 |
|
|
3,006.7 |
|
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|
5,365.3 |
|
|
|
|
|
|
|
|
|
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|
CASH AND CASH EQUIVALENTS AT JUNE 30 |
|
$ |
2,669.7 |
|
|
$ |
4,642.4 |
|
|
|
|
See Notes to Consolidated Condensed Financial Statements.
4
CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
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|
|
|
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|
|
|
|
|
|
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|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Net income (loss) |
|
$ |
822.0 |
|
|
$ |
(252.0 |
) |
|
$ |
1,656.8 |
|
|
$ |
484.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss)1 |
|
|
170.5 |
|
|
|
(345.9 |
) |
|
|
300.7 |
|
|
|
(517.0 |
) |
|
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|
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|
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|
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|
|
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|
Comprehensive income (loss) |
|
$ |
992.5 |
|
|
$ |
(597.9 |
) |
|
$ |
1,957.5 |
|
|
$ |
(32.4 |
) |
|
|
|
|
|
|
1 |
|
The significant components of other comprehensive income (loss) were gains of $172.5
million and $223.3 million from foreign currency translation adjustments for the three months and
six months ended June 30, 2006, respectively, compared to losses from foreign currency translation
adjustments of $247.9 million and $386.4 million for the three months and six months ended June 30,
2005, respectively. Gains from cash flow hedges were $11.5 million and $78.3 million for the three
months and six months ended June 30, 2006, respectively, compared to losses of $104.7 million and
$114.3 million from cash flow hedges for the three months and six months ended June 30, 2005,
respectively. |
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|
See Notes to Consolidated Condensed Financial Statements. |
5
SEGMENT INFORMATION
We operate in one significant business segment pharmaceutical products. Operations of our animal
health business segment are not material and share many of the same economic and operating
characteristics as our pharmaceutical products. Therefore, they are included with pharmaceutical
products for purposes of segment reporting. Our business segments are distinguished by the
ultimate end user of the product: humans or animals. Performance is evaluated based on profit or
loss from operations before income taxes. Income before income taxes for the animal health
business for the second quarter of 2006 and 2005 was $40.9 million and $47.3 million, respectively,
and $75.1 million and $87.3 million for the six months ended June 30, 2006 and 2005, respectively.
SALES BY PRODUCT CATEGORY
Worldwide sales by product category for the three months and six months ended June 30, 2005 and
2004 were as follows:
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Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Net sales to unaffiliated customers |
|
|
|
|
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|
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|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
Neurosciences |
|
$ |
1,686.2 |
|
|
$ |
1,547.4 |
|
|
$ |
3,193.3 |
|
|
$ |
2,975.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endocrinology |
|
|
1,231.2 |
|
|
|
1,141.8 |
|
|
|
2,459.8 |
|
|
|
2,286.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology |
|
|
496.7 |
|
|
|
454.4 |
|
|
|
965.8 |
|
|
|
855.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal health |
|
|
201.0 |
|
|
|
201.0 |
|
|
|
399.3 |
|
|
|
396.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
|
127.5 |
|
|
|
155.7 |
|
|
|
270.6 |
|
|
|
323.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-infectives |
|
|
69.6 |
|
|
|
112.8 |
|
|
|
157.5 |
|
|
|
222.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceuticals |
|
|
54.7 |
|
|
|
54.6 |
|
|
|
135.3 |
|
|
|
105.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
3,866.9 |
|
|
$ |
3,667.7 |
|
|
$ |
7,581.6 |
|
|
$ |
7,165.1 |
|
|
|
|
6
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
BASIS OF PRESENTATION
We have prepared the accompanying unaudited consolidated condensed financial statements in
accordance with the requirements of Form 10-Q and, therefore, they do not include all information
and footnotes necessary for a fair presentation of financial position, results of operations, and
cash flows in conformity with accounting principles generally accepted in the United States (GAAP).
In our opinion, the financial statements reflect all adjustments (including those that are normal
and recurring) that are necessary for a fair presentation of the results of operations for the
periods shown. In preparing financial statements in conformity with GAAP, we must make estimates
and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and
related disclosures at the date of the financial statements and during the reporting period.
Actual results could differ from those estimates.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with
our consolidated financial statements and accompanying notes included in our Annual Report on Form
10-K for the year ended December 31, 2005.
CONTINGENCIES
We are engaged in the following patent litigation matters brought pursuant to procedures set out in
the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984):
|
|
|
Dr. Reddys Laboratories, Ltd. (Reddy), Teva Pharmaceuticals, and Zenith Goldline
Pharmaceuticals, Inc., which was subsequently acquired by Teva Pharmaceuticals (together,
Teva), each submitted abbreviated new drug applications (ANDAs) seeking permission to
market generic versions of Zyprexa® prior to the expiration of our relevant U.S. patent
(expiring in 2011) and alleging that this patent was invalid or not enforceable. We filed
lawsuits against these companies in the U.S. District Court for the Southern District of
Indiana, seeking a ruling that the patent is valid, enforceable and being infringed. The
district court ruled in our favor on all counts on April 14, 2005. We are now awaiting a
decision by the Court of Appeals for the Federal Circuit, which on April 6, 2006, heard
Reddys and Tevas respective appeals of this ruling. We are confident Reddys and Tevas
claims are without merit and we expect to prevail. However, it is not possible to predict
or determine the outcome of this litigation, and accordingly, we can provide no assurance
that we will prevail on appeal. An unfavorable outcome would have a material adverse
impact on our consolidated results of operations, liquidity, and financial position. |
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Barr Laboratories, Inc. (Barr), submitted an ANDA in 2002 seeking permission to market a
generic version of Evistaâ prior to the expiration of our relevant U.S. patents
(expiring in 2012-2017) and alleging that these patents are invalid, not enforceable, or
not infringed. In November 2002, we filed a lawsuit against Barr in the U.S. District Court
for the Southern District of Indiana, seeking a ruling that these patents are valid,
enforceable, and being infringed by Barr. Teva has also submitted an ANDA seeking
permission to market a generic version of Evista. In June 2006, we filed a lawsuit against
Teva in the U.S. District Court for the Southern District of Indiana, seeking a ruling that
our relevant U.S. patents (expiring in 2012-2014) are valid, enforceable, and being
infringed by Teva. No trial date has been set in either case. We believe Barrs and
Tevas claims are without merit and we expect to prevail. However, it is not possible to
predict or determine the outcome of this litigation, and accordingly, we can provide no
assurance that we will prevail. An unfavorable outcome could have a material adverse
impact on our consolidated results of operations, liquidity, and financial position. |
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Sicor Pharmaceuticals, Inc. (Sicor), a subsidiary of Teva, submitted ANDAs in November
2005 seeking permission to market generic versions of Gemzar® prior to the expiration of
our relevant U.S. patents (expiring in 2010 and 2013), and alleging that these patents are
invalid. In February, we filed a lawsuit against Sicor in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid and are being
infringed by Sicor. In response to our lawsuit, Sicor filed a declaratory judgment action
in the U.S. District Court for the Central District of California. No trial date has been
set in either matter. We believe Sicors claims are without merit and we expect to
prevail. However, it is not possible to predict or determine the outcome of this
litigation, and accordingly, we can provide no assurance that we will prevail. An
unfavorable outcome could have a material adverse impact on our consolidated results of
operations. |
In March 2004, the office of the U.S. Attorney for the Eastern District of Pennsylvania advised us
that it has commenced a civil investigation related to our U.S. marketing and promotional
practices, including our communications with physicians and remuneration of physician consultants
and advisors, with respect to Zyprexa, Prozac®, and Prozac Weekly. In October 2005, the U.S.
Attorneys office advised that it is also conducting an inquiry regarding certain rebate agreements
we entered into with a pharmacy benefit manager covering Axid®, Evista, Humalogâ,
Humulinâ, Prozac, and Zyprexa. The inquiry includes a review of Lillys Medicaid best price
reporting related
to the product sales covered by the rebate agreements. We are cooperating with the U.S. Attorney in
these investigations, including providing a broad range of documents
and information relating to the
7
investigations. In June 2005, we received a subpoena from the office of the Attorney General,
Medicaid Fraud Control Unit, of the State of Florida, seeking production of documents relating to
sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa. It is
possible that other Lilly products could become subject to investigation and that the outcome of
these matters could include criminal charges and fines, penalties, or other monetary or nonmonetary
remedies. We cannot predict or determine the outcome of these matters or reasonably estimate the
amount or range of amounts of any fines or penalties that might result from an adverse outcome. It
is possible, however, that an adverse outcome could have a material adverse impact on our
consolidated results of operations, liquidity, and financial position. We have implemented and
continue to review and enhance a broadly based compliance program that includes comprehensive
compliance-related activities designed to ensure that our marketing and promotional practices,
physician communications, remuneration of health care professionals, managed care arrangements, and
Medicaid best price reporting comply with applicable laws and regulations.
We have been named as a defendant in a large number of Zyprexa product liability lawsuits in the
United States and have been notified of many other claims of individuals who have not filed suit.
The lawsuits and unfiled claims (together the claims) allege a variety of injuries from the use
of Zyprexa, with the majority alleging that the product caused or contributed to diabetes or high
blood-glucose levels. The claims seek substantial compensatory and punitive damages and typically
accuse us of inadequately testing for and warning about side effects of Zyprexa. Many of the
claims also allege that we improperly promoted the drug. Almost all of the federal lawsuits are
part of a Multi-District Litigation (MDL) proceeding before The Honorable Jack Weinstein in the
Federal District Court for the Eastern District of New York (MDL No. 1596). The MDL includes three
lawsuits requesting certification of class actions on behalf of those who allegedly suffered
injuries from the administration of Zyprexa. We have entered into agreements with various
plaintiffs counsel halting the running of the statutes of limitation (tolling agreements) with
respect to a number of claimants who do not have lawsuits on file.
Since June 2005, we have entered into agreements with various claimants attorneys involved in U.S.
Zyprexa product liability litigation to settle a majority of the claims. The agreements cover
approximately 10,500 claimants, including a large number of previously filed lawsuits (including
the three purported class actions mentioned above), tolled claims, and other informally asserted
claims. The settlements are being overseen and distributed by court-approved claims
administrators. The agreements are subject to certain conditions, including obtaining full
releases from a specified number of claimants.
The U.S. Zyprexa product liability claims not subject to these agreements include approximately
1,400 lawsuits in the U.S. covering approximately 7,600 claimants, and approximately 850 tolled
claims. In addition, we have been served with a lawsuit seeking class certification in which the
members of the purported class are seeking refunds and medical monitoring. Finally, in early 2005,
we were served with four lawsuits seeking class action status in Canada on behalf of patients who
took Zyprexa. One of these four lawsuits has been certified for residents of Quebec. The
allegations in the Canadian actions are similar to those in the litigation pending in the United
States. We are prepared to continue our vigorous defense of Zyprexa in all remaining cases.
In December 2004, we were served with two lawsuits brought in state court in Louisiana on behalf of
the Louisiana Department of Health and Hospitals, alleging that Zyprexa caused or contributed to
diabetes or high blood-glucose levels, and that we improperly promoted the drug. These cases have
been removed to federal court and are now part of the MDL proceedings in the Eastern District of
New York. In these actions, the Department of Health and Hospitals seeks to recover the costs it
paid for Zyprexa through Medicaid and other drug-benefit programs, as well as the costs the
department alleges it has incurred and will incur to treat Zyprexa-related illnesses. In 2006, we
were served with similar lawsuits filed by the states of Alaska, West Virginia, and Mississippi in
the courts of the respective states.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide
class actions on behalf of all consumers and third-party payors, excluding governmental entities,
which have made or will make payments for their members or insured patients being prescribed
Zyprexa. These actions have now been consolidated into a single lawsuit, which is brought under
certain state consumer protection statutes, the federal civil RICO statute, and common law
theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys
fees. Four additional lawsuits were filed in 2006: two in the Eastern District of New York, one
in the Southern District of Indiana, and one in Indiana state court, all on similar grounds. As
with the product liability suits, these lawsuits allege that we inadequately tested for and warned
about side effects of Zyprexa and improperly promoted the drug.
We have insurance coverage for a portion of our Zyprexa product liability claims exposure. The
third-party insurance carriers have raised defenses to their liability under the policies and are
seeking to rescind the policies. The dispute is now the subject of litigation in the federal court
in Indianapolis against certain of the carriers and in arbitration in Bermuda against other
carriers. While we believe our position is meritorious, there can be no assurance that we will
prevail.
In addition, we have been named as a defendant in numerous other product liability lawsuits
involving primarily diethylstilbestrol (DES) and thimerosal.
8
With respect to the product liability claims currently asserted against us, we have accrued for our
estimated exposures to the extent they are both probable and estimable based on the information
available to us. In addition, we have accrued for certain product liability claims incurred but
not filed to the extent we can formulate a reasonable estimate of their costs. We estimate these
expenses based primarily on historical claims experience and data regarding product usage. Legal
defense costs expected to be incurred in connection with significant product liability loss
contingencies are accrued when probable and reasonably estimable. A portion of the costs
associated with defending and disposing of these suits is covered by insurance. We record
receivables for insurance-related recoveries when it is probable they will be realized. These
receivables are classified as a reduction of the litigation charges on the statement of income. We
estimate insurance recoverables based on existing deductibles, coverage limits, our assessment of
any defenses to coverage that might be raised by the carriers, and the existing and projected
future level of insolvencies among the insurance carriers.
In the second quarter of 2005, we recorded a net pre-tax charge of $1.07 billion for product
liability matters. The $1.07 billion net charge takes into account our estimated recoveries from
our insurance coverage related to these matters. The charge covers the following:
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The cost of the Zyprexa settlements described above; and, |
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Reserves for product liability exposures and defense costs regarding currently known and
expected claims to the extent we can formulate a reasonable estimate of the probable number
and cost of the claims. A substantial majority of these exposures and costs relate to
current and expected Zyprexa claims not included in the settlements. We have estimated
these charges based primarily on historical claims experience, data regarding product
usage, and our historical product liability defense cost experience. |
During 2005, $700.0 million was paid in connection with Zyprexa settlements, while the cash related
to other reserves for product liability exposures and defense costs is expected to be paid out over
the next several years, including 2006. The timing of our insurance recoveries is uncertain.
We cannot predict with certainty the additional number of lawsuits and claims that may be asserted.
In addition, although we believe it is probable, there can be no assurance that the Zyprexa
settlements described above will be concluded. The ultimate resolution of Zyprexa product
liability and related litigation could have a material adverse impact on our consolidated results
of operations, liquidity, and financial position.
Because of the nature of pharmaceutical products, it is possible that we could become subject to
large numbers of product liability claims for other products in the future. We have experienced
difficulties in obtaining product liability insurance due to a very restrictive insurance market,
and therefore will be largely self-insured for future product liability losses. In addition, as
noted above, there is no assurance that we will be able to fully collect from our insurance
carriers on past claims.
In June 2002, we were sued by Ariad Pharmaceuticals, Inc., the Massachusetts Institute of
Technology, the Whitehead Institute for Biomedical Research and the President and Fellows of
Harvard College in the U.S. District Court for the District of Massachusetts alleging that sales of
two of our products, Xigris® and Evista, were inducing the infringement of a patent related to the
discovery of a natural cell signaling phenomenon in the human body and seeking royalties on past
and future sales of these products. We believe that these allegations are without legal merit and
that we will ultimately prevail on these issues. In June 2005, the United States Patent and
Trademark Office commenced a re-examination of the patent in order to consider certain issues
raised by us relating to the validity of the patent. A jury trial commenced in Boston on April 10,
2006 on the patent validity and infringement issues. On May 4, 2006, the jury issued an initial
decision in the case that Xigris and Evista sales infringe the patent. The jury awarded the
plaintiffs approximately $65 million in damages, calculated by applying a 2.3 percent royalty to
all U.S. sales of Xigris and Evista from the date of issuance of the patent through the date of
trial. We will seek to have the jury verdict overturned by the trial court judge, and if
unsuccessful, will appeal the decision to the Court of Appeals for the Federal Circuit. In
addition, a separate bench trial with the U.S. District Court of Massachusetts is scheduled to
begin on August 7, 2006, and will be held on our contention that the patent is unenforceable and
will also consider the patents improper coverage of natural processes.
Also, under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly
known as Superfund, we have been designated as one of several potentially responsible parties with
respect to fewer than 10 sites. Under Superfund, each responsible party may be jointly and
severally liable for the entire amount of the cleanup. We also continue remediation of certain of
our own sites. We have accrued for estimated Superfund cleanup costs, remediation, and certain
other environmental matters. This takes into account, as applicable, available information
regarding site conditions, potential cleanup methods, estimated costs, and the extent to which
other parties can be expected to contribute to payment of those costs. We have reached a settlement
with our liability insurance carriers providing for coverage for certain environmental liabilities.
The litigation accruals and environmental liabilities and the related estimated insurance
recoverables have been reflected on a gross basis as liabilities and assets, respectively, on our
consolidated balance sheets.
9
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity, but could possibly be material to the
consolidated results of operations in any one accounting period.
EARNINGS PER SHARE
Unless otherwise noted in the footnotes, all per-share amounts are presented on a diluted basis,
that is, based on the weighted-average number of outstanding common shares plus the effect of all
potentially dilutive common shares (primarily unexercised stock options). Loss per-share amounts
are presented based on a basic calculation; that is, based on the weighted-average number of
outstanding common shares.
STOCK-BASED COMPENSATION
We adopted Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment
(SFAS 123R), effective January 1, 2005. SFAS 123R requires the recognition of the fair value of
stock-based compensation in net income. Stock-based compensation primarily consists of stock
options and performance awards. We recognized pretax stock-based compensation cost in the amount
of $91.1 million and $100.0 million in the second quarter of 2006 and 2005, respectively. In the
first half of 2006 and 2005, we recognized stock-based compensation expense of $191.3 million and
$208.2 million, respectively.
As of June 30, 2006, the total remaining unrecognized compensation cost related to nonvested stock
options and performance awards amounted to $183.4 million and $102.4 million, respectively, which
will be amortized over the weighted-average remaining requisite service periods, which are
approximately 19 months and 6 months, respectively.
Under our policy, all stock option awards are approved prior to the date of grant and the exercise
price is the average of the high and low market price on the date of grant. The Compensation
Committee of the Board of Directors approves the value of the award and the date of grant. All
option awards for senior management are approved by the Compensation Committee. Options that are
awarded as part of annual total compensation for senior management and other employees are made on
specific grant dates scheduled in advance. With respect to option awards given to new hires, our
policy requires approval of such awards prior to the grant date, and the options are granted on a
pre-determined monthly date immediately following the date of hire.
RETIREMENT BENEFITS
Net pension and retiree health benefit expense included the following components:
|
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Defined Benefit Pension Plans |
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|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Components of net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
68.8 |
|
|
$ |
74.3 |
|
|
$ |
138.1 |
|
|
$ |
154.4 |
|
Interest cost |
|
|
81.5 |
|
|
|
74.2 |
|
|
|
162.2 |
|
|
|
149.0 |
|
Expected return on plan assets |
|
|
(120.8 |
) |
|
|
(112.9 |
) |
|
|
(240.2 |
) |
|
|
(223.0 |
) |
Amortization of prior service cost |
|
|
1.5 |
|
|
|
1.9 |
|
|
|
2.9 |
|
|
|
3.9 |
|
Recognized actuarial loss |
|
|
32.8 |
|
|
|
26.0 |
|
|
|
63.1 |
|
|
|
52.2 |
|
|
|
|
Net periodic benefit cost |
|
$ |
63.8 |
|
|
$ |
63.5 |
|
|
$ |
126.1 |
|
|
$ |
136.5 |
|
|
|
|
10
|
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|
|
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|
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|
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|
Retiree Health Benefit Plans |
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|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Components of net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
16.3 |
|
|
$ |
14.7 |
|
|
$ |
36.0 |
|
|
$ |
29.4 |
|
Interest cost |
|
|
24.4 |
|
|
|
20.0 |
|
|
|
48.8 |
|
|
|
40.1 |
|
Expected return on plan assets |
|
|
(23.0 |
) |
|
|
(18.7 |
) |
|
|
(45.0 |
) |
|
|
(35.7 |
) |
Amortization of prior service cost |
|
|
(3.9 |
) |
|
|
(4.0 |
) |
|
|
(7.7 |
) |
|
|
(8.0 |
) |
Recognized actuarial loss |
|
|
28.8 |
|
|
|
21.5 |
|
|
|
53.9 |
|
|
|
43.1 |
|
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|
|
Net periodic benefit cost |
|
$ |
42.6 |
|
|
$ |
33.5 |
|
|
$ |
86.0 |
|
|
$ |
68.9 |
|
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|
|
In 2006, we expect to contribute approximately $30 million to our defined benefit pension plans
to satisfy minimum funding requirements for the year. In addition, we expect to contribute
approximately $140 million of additional discretionary funding in 2006 to our defined benefit
plans. We also expect to contribute approximately $90 million of discretionary funding to our
postretirement health benefit plans during 2006. As of June 30, 2006, $42.6 million of
contributions have been made to these plans and the majority of our remaining expected
contributions were made in early July 2006.
OTHER INCOME NET
Other income net, was comprised of the following:
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Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Interest expense |
|
$ |
65.8 |
|
|
$ |
12.0 |
|
|
$ |
130.8 |
|
|
$ |
36.6 |
|
Interest income |
|
|
(68.4 |
) |
|
|
(46.3 |
) |
|
|
(128.1 |
) |
|
|
(92.3 |
) |
Joint venture (income) loss |
|
|
(22.5 |
) |
|
|
.5 |
|
|
|
(42.3 |
) |
|
|
13.1 |
|
Other |
|
|
(21.8 |
) |
|
|
(11.6 |
) |
|
|
(39.5 |
) |
|
|
(101.4 |
) |
|
|
|
|
|
$ |
(46.9 |
) |
|
$ |
(45.4 |
) |
|
$ |
(79.1 |
) |
|
$ |
(144.0 |
) |
|
|
|
The joint venture (income) loss represents our share of the Lilly ICOS LLC joint venture results of
operations, net of income taxes.
SHAREHOLDERS EQUITY
As of June 30, 2006, we have purchased $2.58 billion of our previously announced $3.0 billion share
repurchase program. During the six months ended June 30, 2006, we acquired 2.1 million shares
pursuant to this program. We do not expect any share repurchases for the remainder of 2006.
IMPLEMENTATION OF NEW FINANCIAL ACCOUNTING PRONOUNCEMENTS
In the fourth quarter of 2005, we adopted Financial Accounting Standards Board (FASB)
Interpretation (FIN) 47, Accounting for Conditional Asset Retirement Obligations, an
interpretation of FASB Statement No. 143. FIN 47 requires us to record the fair value of a
liability for conditional asset retirement obligations in the period in which it is incurred,
which is adjusted to its present value each subsequent period. In addition, we are required to
capitalize a corresponding amount by increasing the carrying amount of the related long-lived
asset, which is depreciated over the useful life of the related long-lived asset. The adoption of
FIN 47 on December 31, 2005, resulted in a cumulative effect of a change in accounting principle
of $22.0 million, net of income taxes of $11.8 million.
In July 2006, the FASB issued FIN 48, Accounting for Uncertainty in Income Taxes, an
interpretation of FASB Statement No. 109. FIN 48 prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. The Interpretation is effective for fiscal years
beginning after December 15, 2006; therefore, we will be required to adopt this Interpretation in
the first quarter of 2007. We are currently evaluating FIN 48 and have not yet determined the
impact, if any, the adoption of this Interpretation will have on our consolidated financial
position or results of operations.
11
POTENTIAL ASSET IMPAIRMENTS, RESTRUCTURING, AND OTHER SPECIAL CHARGES
As part of our ongoing efforts to maximize performance and efficiencies, including the streamlining
of manufacturing operations and research and development activities, we are discussing the future
of three European facilities, including proposals to close the sites, which include two research
and development sites and one manufacturing site. Any site closures
would be subject to consultations
with employee representatives at the affected sites. Following these consultations, which could
take several months, final recommendations will be made to the Lilly Board of Directors, which must
approve any action. No final decisions have been made about the future of the sites at this time.
However, if the proposals proceed, the majority of the 900 employees plus contractors at those
sites would be laid off and we would attempt to dispose of the facilities. As a consequence, we
would incur severance and impairment charges that would likely be significant.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
OPERATING RESULTS
Executive Overview
I. Financial Results
The second-quarter and first-half 2006 net income was $822.0 million, or $.76 per share, and $1.66
billion, or $1.53 per share, respectively. Second-quarter 2005 net loss and loss per share was
$252.0 million and $.23. However, net income was $484.6 million, or $.44 per share for the first
half of 2005. The net loss and loss per share in the second quarter of 2005 was the result of a
product liability litigation charge of $1.07 billion (pretax) in the quarter. In addition to this
product liability charge, changes in earnings between the periods were driven primarily by
increased sales and decreased cost of sales for the second quarter and first half of 2006, offset
partially by decreased total other income in the first half of 2006.
II. Recent Product and Late-Stage Pipeline Developments
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Gemzar was approved in the U.S. for the treatment of recurrent ovarian cancer in
combination with carboplatin. |
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We submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
for review of ruboxistaurin mesylate (proposed brand name ArxxantTM) as an oral
medication to reduce the risk of vision loss associated with diabetic retinopathy. The FDA
subsequently informed us that our Arxxant application is fileable and will be given a
priority review. We also submitted Arxxant for approval in Europe for the same indication. |
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We submitted a supplemental NDA to the FDA for Cymbaltaâ for the treatment of
generalized anxiety disorder. We are also conducting Phase III studies on Cymbalta for the
treatment of fibromyalgia, a chronic, often debilitating pain disorder. |
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We initiated a Phase III clinical trial to study enzastaurin as a maintenance therapy to
prevent relapse in patients with diffuse large B-cell lymphoma. Enzastaurin, a targeted
oral agent, is also being studied in Phase III trials for the treatment of relapsed
glioblastoma multiforme, an aggressive and malignant form of brain cancer. |
III. Legal, Regulatory, and Other Matters
Certain generic manufacturers have challenged our U.S. compound patent for Zyprexa and are
seeking permission to market generic versions of Zyprexa prior to its patent expiration in 2011.
On April 14, 2005, the U.S. District Court in Indianapolis ruled in our favor on all counts,
upholding our patents. The decision has been appealed.
We have reached agreements with claimants attorneys involved in certain U.S. Zyprexa product
liability litigation to settle a majority of the claims against us relating to the medication.
A large number of claims remain. As a result of our product liability exposures, the
substantial majority of which were related to Zyprexa, we recorded a net pretax charge of $1.07
billion in the second quarter of 2005.
In March 2004, we were notified by the U.S. Attorneys office for the Eastern District of
Pennsylvania that it has commenced a civil investigation relating to our U.S. sales, marketing,
and promotional practices.
We announced that we are discussing the future of three European facilities, including proposals to
close the sites. Any site closures would be subject to consultations with employee representatives
at the affected sites and final approval by the Board of Directors. No final decisions have been
made at this time. If the sites are closed, the majority of the 900 employees would be laid off
and we would record charges that would likely be significant.
12
In the United States, implementation of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA), which provides a prescription drug benefit under the Medicare
program, took effect January 1, 2006. While it is difficult to predict the business impact of
this legislation, we currently anticipate a modest short-term increase in sales. However, in
the long term there is additional risk of increased pricing pressures. While the MMA prohibits
the Secretary of Health and Human Services (HHS) from directly negotiating prescription drug
prices with manufacturers, we expect continued challenges to that prohibition over the next
several years. Also, the MMA retains the authority of the Secretary of HHS to prohibit the
importation of prescription drugs, but we expect Congress to consider several measures that
could remove that authority and allow for the importation of products into the U.S. regardless
of their safety or cost. If adopted, such legislation would likely have a negative effect on
our U.S. sales. We believe there is some chance that the new and expanded prescription drug
coverage for seniors under the MMA will alleviate the perceived need for a federal importation
scheme. Additionally, notwithstanding the federal law prohibiting drug importation,
approximately a dozen states have implemented importation schemes for their citizens, usually
involving a website that links patients to selected Canadian pharmacies. One state has such a
program for its state employees.
As a result of the passage of the MMA, aged and disabled patients jointly eligible for Medicare
and Medicaid began receiving their prescription drug benefits through the Medicare program,
instead of Medicaid, on January 1, 2006. This may relieve some state budget pressures but is
unlikely to result in reduced pricing pressures at the state level. A majority of states have
implemented supplemental rebates and restricted formularies in their Medicaid programs, and
these programs are expected to continue in the post-MMA environment. Moreover, under the 2005
federal Deficit Reduction Act, states will have greater flexibility to impose new cost-sharing
requirements on Medicaid beneficiaries for non-preferred prescription drugs that will result in
certain beneficiaries bearing more of the cost. Several states also are attempting to extend
discounted Medicaid prices to non-Medicaid patients. As a result, we expect pressures on
pharmaceutical pricing to continue.
As it relates to the new Medicare program, we announced in the second quarter of 2006 that we have
temporarily extended our U.S. patient assistance program, LillyAnswers. The temporary extension of
LillyAnswers allows patients who are not enrolled in Medicare Part D access to the LillyAnswers
program until December 31, 2006. We also temporarily extended LillyAnswers for patients who have
enrolled in a Medicare Part D plan and need assistance for Zyprexa and Forteoâ. We have
asked the U.S. Department of Health and Human Services Office of the Inspector General (OIG) for an
opinion on our proposal for an Outside Part D patient assistance program (i.e., the
LillyMedicareAnswers program) which would provide assistance primarily for Zyprexa and Forteo,
beyond the end of this year to patients enrolled in a Medicare Part D plan. We currently
anticipate that the specific LillyAnswers program extension involving Zyprexa and Forteo for
patients enrolled in a Medicare Part D plan will continue to be available until a decision is
rendered by the OIG on our proposal. In order to participate in either the temporary extension as
described above or the new proposed LillyMedicareAnswers program, certain eligibility and
certification requirements must be met.
International operations also are generally subject to extensive price and market regulations,
and there are many proposals for additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls or reduce the value of our
intellectual property protection.
Sales
Second-quarter and first-half 2006 sales growth of 5 and 6 percent, respectively, was driven
primarily by sales growth of Cymbalta, Forteo, Alimtaâ, and Byettaâ. The growth
comparisons also benefited from an estimated $160 million of wholesaler destocking in the first six
months of 2005 as a result of restructuring our arrangements with our U.S. wholesalers in the first
quarter of 2005. Sales in the U.S. increased by $158.4 million, or 8 percent, and $349.0 million,
or 9 percent, for the second quarter and first half of 2006, respectively, compared with the same
periods of 2005. Sales outside the U.S. increased $40.8 million, or 2 percent, and $67.4 million,
or 2 percent, for the second quarter and first half of 2006, respectively. For the second quarter,
sales volume and selling prices each increased sales by 3 percent, while exchange rates decreased
sales by 1 percent. For the first six months of 2006, worldwide sales volume and selling prices
increased 5 percent and 3 percent, respectively, while exchange rates decreased 2 percent.
13
The following tables summarize our net sales activity for the three- and six-month periods ended
June 30, 2006 and 2005:
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Three Months Ended |
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Three Months Ended |
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June 30, |
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Percent |
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June 30, 2006 |
|
2005 |
|
Change |
Product |
|
U.S.1 |
|
Outside U.S. |
|
Total |
|
Total |
|
from 2005 |
|
|
|
|
|
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(Dollars in millions) |
|
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|
|
|
|
|
|
Zyprexa |
|
$ |
542.9 |
|
|
$ |
572.1 |
|
|
$ |
1,115.0 |
|
|
$ |
1,096.8 |
|
|
|
2 |
|
Gemzar |
|
|
150.0 |
|
|
|
193.5 |
|
|
|
343.5 |
|
|
|
343.0 |
|
|
|
0 |
|
Humalog |
|
|
196.6 |
|
|
|
123.9 |
|
|
|
320.5 |
|
|
|
296.2 |
|
|
|
8 |
|
Cymbalta |
|
|
269.9 |
|
|
|
40.5 |
|
|
|
310.4 |
|
|
|
161.4 |
|
|
|
92 |
|
Evista |
|
|
175.0 |
|
|
|
100.5 |
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|
|
275.5 |
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|
261.6 |
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5 |
|
Humulin |
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79.9 |
|
|
|
139.9 |
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|
|
219.8 |
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|
|
249.8 |
|
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(12 |
) |
Animal health products |
|
|
92.7 |
|
|
|
108.3 |
|
|
|
201.0 |
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|
|
201.0 |
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0 |
|
Alimta |
|
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87.7 |
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|
|
65.3 |
|
|
|
153.0 |
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|
111.2 |
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38 |
|
Forteo |
|
|
101.0 |
|
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|
45.1 |
|
|
|
146.1 |
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|
|
101.9 |
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43 |
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Strattera |
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|
125.9 |
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|
18.2 |
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|
144.1 |
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|
|
123.5 |
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17 |
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Humatrope |
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|
52.0 |
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|
56.0 |
|
|
|
108.0 |
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|
|
108.9 |
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(1 |
) |
Actos |
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50.9 |
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41.7 |
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|
|
92.6 |
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|
105.0 |
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(12 |
) |
Fluoxetine products |
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39.5 |
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|
40.5 |
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|
|
80.0 |
|
|
|
114.2 |
|
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(30 |
) |
ReoPro |
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28.3 |
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44.0 |
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|
72.3 |
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|
77.7 |
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(7 |
) |
Anti-infectives |
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3.5 |
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66.1 |
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69.6 |
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|
|
112.8 |
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(38 |
) |
Byetta |
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|
52.1 |
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|
|
|
|
|
|
52.1 |
|
|
|
3.3 |
|
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NM |
Cialis2 |
|
|
0.8 |
|
|
|
49.7 |
|
|
|
50.5 |
|
|
|
45.1 |
|
|
|
12 |
|
Xigris |
|
|
25.1 |
|
|
|
23.3 |
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|
|
48.4 |
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|
57.7 |
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(16 |
) |
Other pharmaceutical
products |
|
|
23.9 |
|
|
|
40.6 |
|
|
|
64.5 |
|
|
|
96.6 |
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(33 |
) |
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Total net sales |
|
$ |
2,097.7 |
|
|
$ |
1,769.2 |
|
|
$ |
3,866.9 |
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|
$ |
3,667.7 |
|
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|
5 |
|
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Six Months Ended |
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|
Six Months Ended |
|
June 30, |
|
Percent |
|
|
June 30, 2006 |
|
2005 |
|
Change |
Product |
|
U.S.1 |
|
Outside U.S. |
|
Total |
|
Total |
|
from 2005 |
|
|
|
|
|
|
(Dollars in millions) |
|
|
|
|
|
|
|
|
Zyprexa |
|
$ |
1,036.8 |
|
|
$ |
1,085.6 |
|
|
$ |
2,122.4 |
|
|
$ |
2,135.0 |
|
|
|
(1 |
) |
Gemzar |
|
|
299.7 |
|
|
|
382.6 |
|
|
|
682.3 |
|
|
|
647.6 |
|
|
|
5 |
|
Humalog |
|
|
385.2 |
|
|
|
239.8 |
|
|
|
625.0 |
|
|
|
582.4 |
|
|
|
7 |
|
Cymbalta |
|
|
475.8 |
|
|
|
67.9 |
|
|
|
543.7 |
|
|
|
268.2 |
|
|
|
103 |
|
Evista |
|
|
324.1 |
|
|
|
192.9 |
|
|
|
517.0 |
|
|
|
510.5 |
|
|
|
1 |
|
Humulin |
|
|
168.1 |
|
|
|
270.2 |
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|
|
438.3 |
|
|
|
506.7 |
|
|
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(13 |
) |
Animal health products |
|
|
176.7 |
|
|
|
222.6 |
|
|
|
399.3 |
|
|
|
396.5 |
|
|
|
1 |
|
Strattera |
|
|
261.2 |
|
|
|
35.2 |
|
|
|
296.4 |
|
|
|
243.2 |
|
|
|
22 |
|
Alimta |
|
|
165.6 |
|
|
|
117.6 |
|
|
|
283.2 |
|
|
|
205.1 |
|
|
|
38 |
|
Actos |
|
|
202.3 |
|
|
|
79.4 |
|
|
|
281.7 |
|
|
|
273.6 |
|
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|
3 |
|
Forteo |
|
|
188.2 |
|
|
|
84.9 |
|
|
|
273.1 |
|
|
|
168.7 |
|
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|
62 |
|
Humatrope |
|
|
100.2 |
|
|
|
104.4 |
|
|
|
204.6 |
|
|
|
213.4 |
|
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(4 |
) |
Fluoxetine products |
|
|
75.6 |
|
|
|
81.8 |
|
|
|
157.4 |
|
|
|
226.7 |
|
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|
(31 |
) |
Anti-infectives |
|
|
24.3 |
|
|
|
133.2 |
|
|
|
157.5 |
|
|
|
222.0 |
|
|
|
(29 |
) |
ReoPro |
|
|
57.8 |
|
|
|
88.6 |
|
|
|
146.4 |
|
|
|
154.4 |
|
|
|
(5 |
) |
Cialis2 |
|
|
1.9 |
|
|
|
104.3 |
|
|
|
106.2 |
|
|
|
84.0 |
|
|
|
26 |
|
Xigris |
|
|
52.9 |
|
|
|
45.7 |
|
|
|
98.6 |
|
|
|
117.3 |
|
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|
(16 |
) |
Byetta |
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|
88.0 |
|
|
|
|
|
|
|
88.0 |
|
|
|
3.3 |
|
|
NM |
Other pharmaceutical
products |
|
|
48.6 |
|
|
|
111.9 |
|
|
|
160.5 |
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|
|
206.5 |
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|
(22 |
) |
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Total net sales |
|
$ |
4,133.0 |
|
|
$ |
3,448.6 |
|
|
$ |
7,581.6 |
|
|
$ |
7,165.1 |
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|
6 |
|
|
|
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|
|
NM Not Meaningful
1 U.S. sales include sales in Puerto Rico.
2 Cialisâ had worldwide second-quarter and first-half 2006 sales of $233.2 million
and $456.1 million, respectively, representing increases of 22 and 34 percent, respectively,
compared with the same periods of 2005. The sales shown in the tables above represent results in
the territories in which we market Cialis exclusively. The remaining sales relate to the
joint-venture territories of Lilly ICOS LLC (North America, excluding Puerto Rico, and Europe).
Our share of the joint-venture territory sales, net of expenses, is
reported in other income net in
our consolidated condensed statements of income.
14
Product Highlights
Zyprexa sales in the U.S. decreased 1 percent and 3 percent in the second quarter and first half of
2006, respectively, compared with the same periods of 2005. This decrease was a result of a
decline in the underlying demand, offset in part by higher net effective selling prices. The
increase in net effective selling prices was partially due to the transition of certain low income
patients from Medicaid to Medicare. Despite the decline in demand as compared to prior year, we
are seeing improving U.S. prescription trends. Specifically, Zyprexas U.S. prescriptions have
held steady during the first six months of 2006. Sales of Zyprexa outside the U.S. increased by 5
percent in the second quarter and 2 percent in the first half of 2006, due to increased demand,
offset partially by the unfavorable impact of foreign exchange rates.
Diabetes care products, composed primarily of Humalog, Humulin, Actosâ, and Byetta, had
worldwide net sales of $701.7 million and $1.47 billion in the second quarter and first half of
2006, respectively, an increase of 5 percent compared with the same periods last year. Diabetes
care revenues in the U.S. increased 6 percent and 9 percent, to $392.6 million and $868.1 million
for the second quarter and first half of 2006, led by sales of Byetta. Diabetes care revenues
outside the U.S. increased 4 percent and remained flat, to $309.1 million and $597.0 million in the
second quarter and first half of 2006, respectively. Humalog sales in the U.S. increased 8 percent
during both the second quarter and first half of 2006, due to higher prices, which were partially
offset by a decline in demand during the second quarter. Humalog sales outside of the U.S.
increased 8 percent and 7 percent during the second quarter and first half of 2006, respectively,
due primarily to increased demand, offset in part by the unfavorable impact of foreign exchange
rates. Humulin sales decreased 22 percent and 19 percent in the U.S. in the second quarter and
first half of 2006, respectively, driven primarily by the decline in demand due to continued
competitive pressures. Humulin sales outside of the U.S. decreased 5 percent and 10 percent during
the second quarter and first half of 2006, respectively, due to decreased demand and the
unfavorable impact of foreign exchange rates. Actos revenues, the majority of which represent
service revenues from a copromotion agreement in the U.S. with Takeda Pharmaceuticals North America
(Takeda), decreased 29 percent and 3 percent in the second quarter and first half of 2006 in the
U.S. Actos is manufactured by Takeda Chemical Industries, Ltd., and sold in the U.S. by Takeda.
As previously disclosed, since our share of revenue from the agreement with Takeda will vary from
quarter to quarter based on contract terms, Actos revenue will not necessarily track with product
sales. As a result, it is difficult to make quarterly comparisons for Actos revenue. Our U.S.
marketing rights with respect to Actos expire in September 2006; however, we will continue
receiving royalties from Takeda. As a result, our U.S. revenues from Actos will decline in 2006
and each subsequent year. Our arrangement in the U.S. ceases after October 2009, although our
arrangement outside the U.S. continues. Sales of Byetta, a first-in-class treatment for type 2
diabetes that we market with Amylin Pharmaceuticals and launched in the U.S. in June 2005, were
$98.6 million and $166.6 million for the second quarter and first half of 2006, respectively. We
report as revenue our 50 percent share of Byettas gross margin and our sales of Byettas pen
delivery devices to Amylin.
Gemzar sales decreased 3 percent and increased 6 percent in the U.S. for the second quarter and
first half of 2006, respectively, reflecting decreased demand due to competitive pressures in the
second quarter. Gemzar sales outside the U.S. increased 3 and 4 percent for the second quarter and
first half of 2006, respectively, due to increased demand, offset partially by the unfavorable
impact of foreign exchange rates.
U.S. sales of Cymbalta, a treatment of major depressive disorder and diabetic peripheral
neuropathic pain, increased 79 percent and 88 percent in the second quarter and first half of 2006,
respectively, reflecting increased demand. Also during the second quarter, Cymbaltas U.S. market
share growth accelerated. Specifically, Cymbaltas U.S. share of new prescriptions increased 0.96
percentage points in the second quarter, compared with a 0.35 percentage point gain
in the first quarter of 2006, per IMS Health, National Prescription Audit Plus 7, July 2006.
Sales outside the U.S. reflect international launches in key markets, including Germany, the U.K.,
Italy, Spain, Mexico, and Brazil.
Evista sales in the U.S. increased 7 percent and 1 percent in the second quarter and first half of
2006, respectively, due to price increases in both periods, offset partially by decreased demand in
the first half of 2006. Evista sales outside the U.S. increased 2
15
percent in the second quarter
and first half of 2006 compared with the same periods of 2005, due to increased demand, offset
partially by lower prices and the unfavorable impact of foreign exchange rates.
Stratteraâ, a treatment for attention-deficit hyperactivity disorder (ADHD) in children,
adolescents, and adults, generated increases in U.S. sales of 13 percent and 17 percent for the
second quarter and first half of 2006, compared with the same periods in 2005. The sales increases
for both periods were primarily due to reductions in the U.S. wholesaler inventory levels in 2005
and higher prices, offset partially by a decline in demand in the U.S.
Alimta, a treatment for malignant pleural mesothelioma and second-line treatment of non-small-cell
lung cancer, generated increased U.S. sales of 26 percent and 25 percent in the second quarter and
first half of 2006, respectively; while sales outside the U.S. increased 56 percent and 63 percent
for the same periods in 2005.
Forteo, a treatment for severe osteoporosis, increased 43 percent and 67 percent in the U.S. in the
second quarter and first half of 2006, respectively; while sales outside the U.S. increased 45
percent and 52 percent for the same periods. Increased sales in the U.S. were due in part to
greater access to medical coverage through the MMA program.
Cialis sales in the second quarter and first half of 2006 were comprised of $50.5 million and
$106.2 million of sales in our territories, respectively, which are reported in our net sales, and
$182.7 million and $349.9 million of sales in the joint-venture territories. Within the
joint-venture territories, the U.S. sales of Cialis were $93.8 million and $176.3 million in the
second quarter and first half of 2006, respectively, compared with $71.1 million and $113.9 million
in the same periods of 2005. Cialis sales in our territories are reported in revenue, while our 50
percent share of the joint-venture territory sales, net of expenses, is reported in other income
net. Cialis sales growth reflects both gains in market share and growth of the erectile
dysfunction market during the second quarter and first half of 2006.
Gross Margin, Costs, and Expenses
For the second quarter of 2006, gross margins increased 1.5 percentage points, to 77.7 percent of
net sales, compared with the second quarter of 2005. For the first half of 2006, gross margins
increased 2.1 percentage points, to 78.0 percent of net sales, compared with the first half of
2005. This increase was primarily due to favorable product mix and the favorable impact of foreign
exchange rates, partially offset by higher manufacturing-related costs.
Operating expenses (the aggregate of research and development and marketing and administrative
expenses) increased 5 percent for both the second quarter and first half of 2006. Investment in
research and development increased 2 percent, to $774.8 million, and 3 percent, to $1.52 billion,
for the second quarter and first half of 2006, respectively, due primarily to increased discovery
research expenses. Marketing and administrative expenses increased 8 percent, to $1.24 billion,
and 6 percent, to $2.38 billion, for the second quarter and first half of 2006, respectively,
primarily due to increased marketing expenses in support of newer products, offset partially by the
impact of foreign exchange rates.
Other income net consists of interest expense, interest income, the after-tax operating results
of the Lilly ICOS joint venture, and all other income and expense items.
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Second-quarter and first-half 2006 interest expense increased $53.8 million, to $65.8
million, and $94.2 million to $130.8 million, respectively, as a result of higher interest
rates and less capitalized interest due to the completion in late 2005 of certain
manufacturing facilities. |
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|
|
Interest income increased $22.1 million, to $68.4 million and $35.8 million to $128.1
million for the second quarter and first half of 2006, respectively, due to higher interest
rates. |
|
|
|
|
The Lilly ICOS joint-venture income was $22.5 million in the second quarter of 2006,
compared with a loss of $.5 million in the second quarter of 2005. For the first half of
2006, income was $42.3 million, compared with a loss of $13.1 million in the first half of
2005. The increase in both periods was due to increased Cialis sales and decreased selling
and marketing expenses. |
|
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|
Net other income and expense items increased $10.2 million to $21.8 million for
second-quarter 2006 and decreased $61.9 million to $39.5 million for first-half 2006. The
first-half decrease is largely a result of less income from business development
transactions. |
We incurred a tax expense of $218.5 million and $440.4 million, for the second quarter and first
half of 2006, respectively, representing an effective tax rate of 21 percent in both periods.
Comparisons to prior year are not meaningful due to the net loss before income taxes experienced in
the second quarter of 2005.
16
FINANCIAL CONDITION
As of June 30, 2006, cash, cash equivalents, and short-term investments totaled $4.59 billion
compared with $5.04 billion at December 31, 2005. Cash flow from operations of $942.2 million
during the first six months of 2006 was more than offset by dividends paid of $864.6 million, net
capital expenditures of $392.1 million, and repurchases of common stock of $122.1 million.
Total debt at June 30, 2006, was $6.32 billion, a decrease of $181.6 million from December 31,
2005. Our current debt ratings from Standard & Poors and Moodys remain at AA and Aa3,
respectively.
We believe that cash generated from operations, along with available cash and cash equivalents,
will be sufficient to fund our operating needs, including debt service, capital expenditures,
dividends, and taxes in 2006. We believe that amounts available through our existing commercial
paper program should be adequate to fund maturities of short-term borrowings, if necessary. We
currently have $1.23 billion of unused committed bank credit facilities, $1.20 billion of which
backs our commercial paper program. We currently expect to repay approximately $1.5 billion of
debt during 2006, using available cash. Various risks and uncertainties, including those
discussed in the Financial Expectations for 2006 section, may affect our operating results and
cash generated from operations.
LEGAL AND REGULATORY MATTERS
We are engaged in the following patent litigation matters brought pursuant to procedures set out in
the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984):
|
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Dr. Reddys Laboratories, Ltd. (Reddy), Teva Pharmaceuticals, and Zenith Goldline
Pharmaceuticals, Inc., which was subsequently acquired by Teva Pharmaceuticals (together,
Teva), each submitted abbreviated new drug applications (ANDAs) seeking permission to
market generic versions of Zyprexa prior to the expiration of our relevant U.S. patent
(expiring in 2011) and alleging that this patent was invalid or not enforceable. We filed
lawsuits against these companies in the U.S. District Court for the Southern District of
Indiana, seeking a ruling that the patent is valid, enforceable and being infringed. The
district court ruled in our favor on all counts on April 14, 2005. We are now awaiting a
decision by the Court of Appeals for the Federal Circuit, which on April 6, 2006, heard
Reddys and Tevas respective appeals of this ruling. We are confident Reddys and Tevas
claims are without merit and we expect to prevail. However, it is not possible to predict
or determine the outcome of this litigation, and accordingly, we can provide no assurance
that we will prevail on appeal. An unfavorable outcome would have a material adverse
impact on our consolidated results of operations, liquidity, and financial position. |
|
|
|
|
Barr Laboratories, Inc. (Barr), submitted an ANDA in 2002 seeking permission to market a
generic version of Evista prior to the expiration of our relevant U.S. patents (expiring in
2012-2017) and alleging that these patents are invalid, not enforceable, or not infringed.
In November 2002, we filed a lawsuit against Barr in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid, enforceable,
and being infringed by Barr. Teva has also submitted an ANDA seeking permission to market
a generic version of Evista. In June 2006, we filed a lawsuit against Teva in the U.S.
District Court for the Southern District of Indiana, seeking a ruling that our relevant
U.S. patents (expiring in 2012-2014) are valid, enforceable, and being infringed by Teva.
No trial date has been set in either case. We believe Barrs and Tevas claims are without
merit and we expect to prevail. However, it is not possible to predict or determine the
outcome of this litigation, and accordingly, we can provide no assurance that we will
prevail. An unfavorable outcome could have a material adverse impact on our consolidated
results of operations, liquidity, and financial position. |
|
|
|
|
Sicor Pharmaceuticals, Inc. (Sicor), a subsidiary of Teva, submitted ANDAs in November
2005 seeking permission to market generic versions of Gemzar prior to the expiration of our
relevant U.S. patents (expiring in 2010 and 2013), and alleging that these patents are invalid. In February, we filed a
lawsuit against Sicor in the U.S. District Court for the Southern District of Indiana,
seeking a ruling that these patents are valid and are being infringed by Sicor. In response
to our lawsuit, Sicor filed a declaratory judgment action in the U.S. District Court for the
Central District of California. No trial date has been set in either matter. We believe
Sicors claims are without merit and we expect to prevail. However, it is not possible to
predict or determine the outcome of this litigation, and accordingly, we can provide no
assurance that we will prevail. An unfavorable outcome could have a material adverse impact
on our consolidated results of operations. |
In March 2004, the office of the U.S. Attorney for the Eastern District of Pennsylvania advised us
that it has commenced a civil investigation related to our U.S. marketing and promotional
practices, including our communications with physicians and remuneration of physician consultants
and advisors, with respect to Zyprexa, Prozac, and Prozac Weekly. In October 2005, the U.S.
Attorneys office advised that it is also conducting an inquiry regarding certain rebate agreements
we entered into with a pharmacy benefit manager covering Axid, Evista, Humalog, Humulin, Prozac,
and Zyprexa. The inquiry includes a review of Lillys Medicaid best price reporting related to the
product sales covered by the rebate agreements. We are cooperating with the U.S.
17
Attorney
in these
investigations, including providing a broad range of documents and information relating to the
investigations. In June 2005, we received a subpoena from the office of the Attorney General,
Medicaid Fraud Control Unit, of the State of Florida, seeking production of documents relating to
sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa. It is
possible that other Lilly products could become subject to investigation and that the outcome of
these matters could include criminal charges and fines, penalties, or other monetary or nonmonetary
remedies. We cannot predict or determine the outcome of these matters or reasonably estimate the
amount or range of amounts of any fines or penalties that might result from an adverse outcome. It
is possible, however, that an adverse outcome could have a material adverse impact on our
consolidated results of operations, liquidity, and financial position. We have implemented and
continue to review and enhance a broadly based compliance program that includes comprehensive
compliance-related activities designed to ensure that our marketing and promotional practices,
physician communications, remuneration of health care professionals, managed care arrangements, and
Medicaid best price reporting comply with applicable laws and regulations.
We have been named as a defendant in a large number of Zyprexa product liability lawsuits in the
United States and have been notified of many other claims of individuals who have not filed suit.
The lawsuits and unfiled claims (together the claims) allege a variety of injuries from the use
of Zyprexa, with the majority alleging that the product caused or contributed to diabetes or high
blood-glucose levels. The claims seek substantial compensatory and punitive damages and typically
accuse us of inadequately testing for and warning about side effects of Zyprexa. Many of the
claims also allege that we improperly promoted the drug. Almost all of the federal lawsuits are
part of a Multi-District Litigation (MDL) proceeding before The Honorable Jack Weinstein in the
Federal District Court for the Eastern District of New York (MDL No. 1596). The MDL includes three
lawsuits requesting certification of class actions on behalf of those who allegedly suffered
injuries from the administration of Zyprexa. We have entered into agreements with various
plaintiffs counsel halting the running of the statutes of limitation (tolling agreements) with
respect to a number of claimants who do not have lawsuits on file.
Since June 2005, we have entered into agreements with various claimants attorneys involved in U.S.
Zyprexa product liability litigation to settle a majority of the claims. The agreements cover
approximately 10,500 claimants, including a large number of previously filed lawsuits (including
the three purported class actions mentioned above), tolled claims, and other informally asserted
claims. The settlements are being overseen and distributed by court-approved claims
administrators. The agreements are subject to certain conditions, including obtaining full
releases from a specified number of claimants.
The U.S. Zyprexa product liability claims not subject to these agreements include approximately
1,400 lawsuits in the U.S. covering approximately 7,600 claimants, and approximately 850 tolled
claims. In addition, we have been served with a lawsuit seeking class certification in which the
members of the purported class are seeking refunds and medical monitoring. Finally, in early 2005,
we were served with four lawsuits seeking class action status in Canada on behalf of patients who
took Zyprexa. One of these four lawsuits has been certified for residents of Quebec. The
allegations in the Canadian actions are similar to those in the litigation pending in the United
States. We are prepared to continue our vigorous defense of Zyprexa in all remaining cases.
In December 2004, we were served with two lawsuits brought in state court in Louisiana on behalf of
the Louisiana Department of Health and Hospitals, alleging that Zyprexa caused or contributed to
diabetes or high blood-glucose levels, and that we improperly promoted the drug. These cases have
been removed to federal court and are now part of the MDL proceedings in the Eastern District of
New York. In these actions, the Department of Health and Hospitals
seeks to recover the costs it paid for Zyprexa through Medicaid and other drug-benefit programs, as
well as the costs the department alleges it has incurred and will incur to treat Zyprexa-related
illnesses. In 2006, we were served with similar lawsuits filed by the states of Alaska, West
Virginia, and Mississippi in the courts of the respective states.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide
class actions on behalf of all consumers and third-party payors, excluding governmental entities,
which have made or will make payments for their members or insured patients being prescribed
Zyprexa. These actions have now been consolidated into a single lawsuit, which is brought under
certain state consumer protection statutes, the federal civil RICO statute, and common law
theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys
fees. Four additional lawsuits were filed in 2006: two in the Eastern District of New York, one
in the Southern District of Indiana, and one in Indiana state court, all on similar grounds. As
with the product liability suits, these lawsuits allege that we inadequately tested for and warned
about side effects of Zyprexa and improperly promoted the drug.
We have insurance coverage for a portion of our Zyprexa product liability claims exposure. The
third-party insurance carriers have raised defenses to their liability under the policies and are
seeking to rescind the policies. The dispute is now the subject of litigation in the federal court
in Indianapolis against certain of the carriers and in arbitration in Bermuda against other
carriers. While we believe our position is meritorious, there can be no assurance that we will
prevail.
In addition, we have been named as a defendant in numerous other product liability lawsuits
involving primarily diethylstilbestrol (DES) and thimerosal.
18
With respect to the product liability claims currently asserted against us, we have accrued for our
estimated exposures to the extent they are both probable and estimable based on the information
available to us. In addition, we have accrued for certain product liability claims incurred but
not filed to the extent we can formulate a reasonable estimate of their costs. We estimate these
expenses based primarily on historical claims experience and data regarding product usage. Legal
defense costs expected to be incurred in connection with significant product liability loss
contingencies are accrued when probable and reasonably estimable. A portion of the costs
associated with defending and disposing of these suits is covered by insurance. We record
receivables for insurance-related recoveries when it is probable they will be realized. These
receivables are classified as a reduction of the litigation charges on the statement of income. We
estimate insurance recoverables based on existing deductibles, coverage limits, our assessment of
any defenses to coverage that might be raised by the carriers, and the existing and projected
future level of insolvencies among the insurance carriers.
In the second quarter of 2005, we recorded a net pre-tax charge of $1.07 billion for product
liability matters. The $1.07 billion net charge takes into account our estimated recoveries from
our insurance coverage related to these matters. The charge covers the following:
|
|
|
The cost of the Zyprexa settlements described above; and, |
|
|
|
|
Reserves for product liability exposures and defense costs regarding currently known and
expected claims to the extent we can formulate a reasonable estimate of the probable number
and cost of the claims. A substantial majority of these exposures and costs relate to
current and expected Zyprexa claims not included in the settlements. We have estimated
these charges based primarily on historical claims experience, data regarding product
usage, and our historical product liability defense cost experience. |
During 2005, $700.0 million was paid in connection with Zyprexa settlements, while the cash related
to other reserves for product liability exposures and defense costs is expected to be paid out over
the next several years, including 2006. The timing of our insurance recoveries is uncertain.
We cannot predict with certainty the additional number of lawsuits and claims that may be asserted.
In addition, although we believe it is probable, there can be no assurance that the Zyprexa
settlements described above will be concluded. The ultimate resolution of Zyprexa product
liability and related litigation could have a material adverse impact on our consolidated results
of operations, liquidity, and financial position.
Because of the nature of pharmaceutical products, it is possible that we could become subject to
large numbers of product liability claims for other products in the future. We have experienced
difficulties in obtaining product liability insurance due to a very restrictive insurance market,
and therefore will be largely self-insured for future product
liability losses. In addition, as noted above, there is no assurance that we will be able to fully
collect from our insurance carriers on past claims.
In June 2002, we were sued by Ariad Pharmaceuticals, Inc., the Massachusetts Institute of
Technology, the Whitehead Institute for Biomedical Research and the President and Fellows of
Harvard College in the U.S. District Court for the District of Massachusetts alleging that sales of
two of our products, Xigris and Evista, were inducing the infringement of a patent related to the
discovery of a natural cell signaling phenomenon in the human body and seeking royalties on past
and future sales of these products. We believe that these allegations are without legal merit and
that we will ultimately prevail on these issues. In June 2005, the United States Patent and
Trademark Office commenced a re-examination of the patent in order to consider certain issues
raised by us relating to the validity of the patent. A jury trial commenced in Boston on April 10,
2006 on the patent validity and infringement issues. On May 4, 2006, the jury issued an initial
decision in the case that Xigris and Evista sales infringe the patent. The jury awarded the
plaintiffs approximately $65 million in damages, calculated by applying a 2.3 percent royalty to
all U.S. sales of Xigris and Evista from the date of issuance of the patent through the date of
trial. We will seek to have the jury verdict overturned by the trial court judge, and if
unsuccessful, will appeal the decision to the Court of Appeals for the Federal Circuit. In
addition, a separate bench trial with the U.S. District Court of Massachusetts is scheduled to
begin on August 7, 2006, and will be held on our contention that the patent is unenforceable and
will also consider the patents improper coverage of natural processes.
Also, under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly
known as Superfund, we have been designated as one of several potentially responsible parties with
respect to fewer than 10 sites. Under Superfund, each responsible party may be jointly and
severally liable for the entire amount of the cleanup. We also continue remediation of certain of
our own sites. We have accrued for estimated Superfund cleanup costs, remediation, and certain
other environmental matters. This takes into account, as applicable, available information
regarding site conditions, potential cleanup methods, estimated costs, and the extent to which
other parties can be expected to contribute to payment of those costs. We have reached a
settlement with our liability insurance carriers providing for coverage for certain environmental
liabilities.
19
The litigation accruals and environmental liabilities and the related estimated insurance
recoverables have been reflected on a gross basis as liabilities and assets, respectively, on our
consolidated balance sheets.
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity, but could possibly be material to the
consolidated results of operations in any one accounting period.
FINANCIAL EXPECTATIONS FOR 2006
We expect third-quarter earnings per share of $.77 to $.79, representing 5 percent to 8 percent
growth compared with third-quarter 2005 earnings per share of $.73. For the full year of 2006, we
expect earnings per share to be in the range of $3.10 to $3.20. This guidance excludes future
material unusual items, such as any charges related to the three potential European site closures
discussed previously. We expect full-year 2006 sales to grow at approximately the low end of our
previous guidance of 7 percent to 9 percent. In addition, we expect gross margins as a percent of
sales to improve modestly compared with 2005, operating expenses to grow in the mid-single digits
in the aggregate, and other income net, to contribute approximately $175 million to $275 million.
Excluding the tax associated with the potential charges discussed above, we also anticipate the
effective tax rate to be approximately 21 percent. In terms of cash flow, we expect capital
expenditures to be flat at about $1.4 billion in 2006.
We caution investors that any forward-looking statements or projections made by us, including those
above, are based on managements belief at the time they are made. However, they are subject to
risks and uncertainties. Actual results could differ materially and will depend on, among other
things, the continuing growth of our currently marketed products; developments with competitive
products; the timing and scope of regulatory approvals and the success of our new product launches;
asset impairments, restructurings, and acquisitions of compounds under development resulting in
acquired in-process research and development charges; foreign exchange rates; wholesaler inventory
changes; the outcome of the Zyprexa patent appeal; other regulatory developments, government
investigations, patent disputes and litigation; and the impact of governmental actions regarding
pricing, importation, and reimbursement for pharmaceuticals. Other factors that may affect our
operations and prospects are discussed in Item 1A of our 2005 Form 10-K, Risk Factors. We
undertake no duty to update these forward-looking statements.
AVAILABLE INFORMATION ON OUR WEBSITE
We make available through our company website, free of charge, our company filings with the
Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electronically
file them with, or furnish them to, the SEC. The reports we make available include annual reports
on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements,
registration statements, and any amendments to those documents.
The website link to our SEC filings is http://investor.lilly.com/edgar.cfm.
Item 4. Controls and Procedures
(a) |
|
Evaluation of Disclosure Controls and Procedures. Under applicable SEC regulations,
management of a reporting company, with the participation of the principal executive officer
and principal financial officer, must periodically evaluate the companys disclosure controls
and procedures, which are defined generally as controls and other procedures of a reporting
company designed to ensure that information required to be disclosed by the reporting company
in its periodic reports filed with the commission (such as this Form 10-Q) is recorded,
processed, summarized, and reported on a timely basis. |
|
|
|
Our management, with the participation of Sidney Taurel, chairman and chief executive officer,
and Derica W. Rice, senior vice president and chief financial officer, evaluated our disclosure
controls and procedures as of June 30, 2006, and concluded that they are effective. |
(b) |
|
Changes in Internal Controls. During the second quarter of 2006, there were no changes in
our internal control over financial reporting that materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting. |
20
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
See Part I, Item 2, Managements Discussion and Analysis, Legal and Regulatory Matters, for
information on various legal proceedings, including but not limited to:
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The U.S. patent litigation involving Zyprexa, Evista, and Gemzar |
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The civil investigation by the U.S. Attorney for the Eastern District of Pennsylvania
relating to our U.S. sales, marketing, and promotional practices |
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The Zyprexa product liability and related litigation, including claims brought on behalf
of healthcare payors |
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The legal proceedings we have filed against several of our product liability insurance
carriers with respect to our coverage for the Zyprexa product liability claims |
That information is incorporated into this Item by reference.
Other Product Liability Litigation
We refer to Part I, Item 3, of our Form 10-K annual report for 2005 for the discussion of product
liability litigation involving diethylstilbestrol (DES) and vaccines containing the preservative
thimerosal. In the DES litigation, we have been named as a defendant in approximately 80 suits
involving approximately 170 claimants. In the thimerosal litigation, we have been named as a
defendant in approximately 360 suits with approximately 975 claimants.
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity but could possibly be material to the
consolidated results of operations in any one accounting period.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table summarizes the activity related to repurchases of our equity securities during
the three-month period ended June 30, 2006:
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Total Number of |
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Shares Purchased as |
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Approximate Dollar |
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Part of Publicly |
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Value of Shares that May |
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Total Number of |
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Average Price Paid |
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Announced Plans or |
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Yet Be Purchased Under |
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Shares Purchased |
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per Share |
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Programs |
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the Plans or Programs |
Period |
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(a) |
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(b) |
|
(c) |
|
(d) |
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(in thousands) |
|
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(in thousands) |
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(Dollars in millions) |
April 2006 |
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3 |
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$ |
53.49 |
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|
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$ |
419.2 |
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May 2006 |
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|
15 |
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|
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52.52 |
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|
|
419.2 |
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June 2006 |
|
|
10 |
|
|
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54.02 |
|
|
|
|
|
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419.2 |
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Total |
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28 |
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The amounts presented in columns (a) and (b) above include purchases of common stock related to
employee stock option exercises. The amounts presented in columns (c) and (d) in the above table
represent activity related only to our $3.0 billion share repurchase program announced in March
2000. As of June 30, 2006, we have purchased $2.58 billion related to this program. During the
second quarter of 2006, no shares were repurchased pursuant to this program and we do not expect to
purchase any shares under this program during the remainder of 2006.
21
Item 6. Exhibits
The following documents are filed as exhibits to this Report:
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EXHIBIT 10.
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Master Settlement Agreement regarding Zyprexa product liability claims, filed
here in its entirety to include its Exhibit A, which was inadvertently omitted from our
Form 10-Q for the quarter ended September 30, 2005 |
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EXHIBIT 11.
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Statement re: Computation of Earnings (Loss) per Share |
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EXHIBIT 12.
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Statement re: Computation of Ratio of Earnings to Fixed Charges |
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EXHIBIT 31.1
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Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the Board and Chief
Executive Officer |
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EXHIBIT 31.2
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Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President and Chief
Financial Officer |
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EXHIBIT 32.
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Section 1350 Certification |
22
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this Report to be signed on its behalf by the undersigned thereunto duly authorized.
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ELI LILLY AND COMPANY
(Registrant)
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Date August 1, 2006 |
/s/ James B. Lootens
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James B. Lootens |
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Secretary and Deputy General Counsel |
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Date August 1, 2006 |
/s/ Arnold C. Hanish
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Arnold C. Hanish |
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Executive Director, Finance, and
Chief Accounting Officer |
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23
INDEX TO EXHIBITS
The following documents are filed as a part of this Report:
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Exhibit |
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EXHIBIT 10.
|
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Master Settlement Agreement regarding Zyprexa product liability
claims, filed here in its entirety to include its Exhibit A, which was
inadvertently omitted from our Form 10-Q for the quarter ended September 30,
2005 |
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EXHIBIT 11.
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Statement re: Computation of Earnings (Loss) per Share |
|
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EXHIBIT 12.
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Statement re: Computation of Ratio of Earnings to Fixed Charges |
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EXHIBIT 31.1
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Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the Board
and Chief Executive Officer |
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EXHIBIT 31.2
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Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President
and Chief Financial Officer |
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EXHIBIT 32.
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Section 1350 Certification |
24
exv10
Exhibit 10
CONFIDENTIAL MASTER SETTLEMENT AGREEMENT
CONFIDENTIAL
MASTER SETTLEMENT AGREEMENT
I. INTRODUCTION
Eli Lilly and Company, a corporation (hereinafter defined in section III.C as Lilly) and
certain plaintiffs counsel representing Zyprexa claimants, including all plaintiffs counsel who
are members of the Plaintiffs Steering Committee (PSC) appointed in In re Zyprexa® Products
Liability Litigation, MDL No. 1596, in the United States District Court for the Eastern District of
New York and other plaintiffs counsel representing Zyprexa claimants have reached a confidential
settlement of certain Zyprexa actions, disputes and claims subject to the terms and conditions set
forth in this document. The matters included in the settlement are: a) cases pending in various
state and federal courts, including the multi-district litigation, In re Zyprexa Products Liability
Litigation, MDL No. 1596, pending before the Honorable Jack Weinstein (MDL); b) claims subject to
a tolling agreement; or c) informally asserted claims. These lawsuits and claims are collectively
referred to as Participating Claimants (hereinafter defined in Section III.A). Notwithstanding
the generality of the foregoing, Participating Claimants are expressly limited to those cases and
claims that are being handled or controlled by the attorneys and law firms who are members of the
PSC or other non-PSC law firms (Participating Law Firms) that are identified on the lists
submitted to Lilly in accordance with Section IV.D below.
The terms and conditions of this Confidential Master Settlement Agreement (Agreement) are as
follows:
II. RECITALS
Each of the Participating Claimants has asserted a claim against Lilly. Lilly disputes
1
these
claims and denies that it has any liability with respect to these claims.
In an effort to resolve their outstanding disputes, Participating Claimants and Lilly have
reached a settlement of all actual or potential claims that have arisen between them relating to
Participating Claimants use of Zyprexa, in accordance with the provisions of this Agreement.
III. DEFINITIONS
A. PARTICIPATING CLAIMANTS
Participating Claimants as used in this Agreement shall refer to those persons or derivative
claimants who are claiming an injury due to the use of Zyprexa and whose cases and claims are
subject to the terms of this Agreement. A final list of Participating Claimants has been provided
to Lilly. This list contains confidential and private information regarding each individual
claimant and, as such, will be kept by Lilly, the trustee for the Participating Law Firms and the
Special Settlement Masters in a separate file as an addendum to this Agreement. Each Participating
Claimant who wishes to resolve his or her claim pursuant to the terms of this Agreement shall be
entitled to participate in a claims review process and to receive compensation, if any, as may be
awarded by the Special Settlement Masters and upon execution of the Confidential Individual Release
attached hereto as Exhibit A, and in accordance with the terms of this Agreement. Prior to signing
a Confidential Individual Release (Exhibit A), a Participating Claimant may (i) withdraw from the
claims administration process established by the Special Settlement Masters or (ii) reject the
Settlement Amount that may be offered by the Special Settlement Masters, and thereafter pursue or
dismiss his or her claim, as may be appropriate.
2
B. PARTICIPATING LAW FIRMS
Participating Law Firms are the law firms and all attorney members within each firm, that
represent the Participating Claimants whose cases and/or claims are the subject of this Agreement.
Participating Law Firms comprise law firms and attorneys who were appointed as members of the PSC
for MDL No. 1596, as well as non-PSC law firms and attorneys. A list of Participating Law Firms
has been provided to Lilly.
C. LILLY
Lilly as used and referred to in this Agreement shall include Eli Lilly and Company, a
corporation, and the entire company, its officers, directors, employees and shareholders, and its
past, present and future parents, subsidiaries, affiliates, controlling persons, suppliers,
distributors, contractors, agents, assigns, servants, counsel and insurers, and all of their
officers, directors, employees, shareholders, predecessors, successors, assigns, heirs, executors,
estate administrators or personal representatives (or the equivalent thereto).
D. SPECIAL SETTLEMENT MASTERS
Pursuant to Case Management Order No. 12, Kenneth R. Feinberg, Michael K. Rozen, Honorable
John K. Trotter (retired), and Catherine Yanni are appointed as Special Settlement Masters to
assist in the claims administration process described in this Agreement. The powers and
responsibilities of the Special Settlement Masters will be specified in subsequent Case Management
Orders entered by the Court in MDL No. 1596.
3
IV. AGREEMENT
A. AUTHORITY OF COUNSEL
Each Participating Law Firm warrants and represents that it has provided a list of its
Participating Claimants who have asserted a claim against Lilly arising out of the use of Zyprexa.
Each Participating Law Firm warrants and represents that they represent the Participating Claimants
set forth on their respective list. Each Participating Law Firm further warrants and represents
that it will recommend to each of its Participating Claimants that they participate in a settlement
process to be jointly established by the Participating Law Firms and the Special Settlement
Masters.
B. BASIC AGREEMENT
For and in consideration of a release of all past, existing, and future claims relating to
Zyprexa, whether known or unknown, and other agreements as set forth herein, and in complete
settlement of the cases and/or claims asserted by Participating Claimants, Lilly hereby agrees to
make payment to Participating Claimants as described below.
C. SETTLEMENT EFFORTS/WAIVER OF STATUTE OF LIMITATIONS
Participating Claimants, Participating Law Firms and Lilly acknowledge and agree that there
will need to be substantial efforts by all concerned to effectuate the terms of this Agreement,
including efforts to provide appropriate client disclosures, obtain adequate consent, prepare
individual releases, and otherwise carry out the terms of this Agreement. Participating Claimants,
Participating Law Firms and Lilly agree to (i) exercise best efforts toward the resolution of these
cases under the terms of this Agreement, and (ii) jointly seek a stay of any
4
case, including but
not limited to case specific or generic discovery or trials, which a Participating Claimant has
pending in any court while the parties continue their best efforts to finalize the settlement of
the claims subject to this Agreement.
Further, in order to avoid the necessity of filing or pursuing a Zyprexa related claim, Lilly
hereby agrees with respect to all Participating Claimants to waive any statute of limitations
defense that it may otherwise have against any such Participating Claimant, subject only to the
following limitations. In the event that the conditions of this settlement are not met, or any
Participating Claimant does not resolve his or her case and/or claim under this agreement, then
Lilly hereby agrees to waive any applicable statute of limitations defense that it otherwise may
have for the time commencing from the earlier of (i) June 8, 2005, the date the Memorandum of
Understanding (MOU) was signed, or (ii) the date on which any tolling agreement was entered into
between Lilly and the Participating Claimant, in each case until 30 days after notice that the
conditions of this Agreement have not been met or 30 days notice that the Participating Claimants
claim is not resolved under this Agreement, whichever event occurs sooner. All tolling agreements
otherwise entered into between a Participating Claimant and Lilly are otherwise terminated and
superseded by this Agreement, except as provided above.
Accordingly, the Participating Law Firms and Participating Claimants may agree to promptly
dismiss without prejudice any pending lawsuits.
D. PARTICIPATING CLAIMANTS AND LAW FIRMS
This Agreement is subject to the Participating Law Firms providing Lilly with the following
information:
5
1. A list of Participating Claimants numbering no fewer than 7,993. Pursuant to the terms of
the MOU dated June 8, 2005, the Participating Law Firms have submitted a list to Lilly of
Participating Claimants, which exceeds the required 7,993 claimants and which identifies the
claimant or claim (such as the claimants full name, social security number and/or date of birth).
Each Participating Law Firm warrants and represents that the list provided to Lilly includes 100%
of their represented Zyprexa clients. The Participating Claimants and claims identified herein
shall constitute the total universe of claims subject to this Master Settlement Agreement. Even
though Participating Law Firms have provided a list of claimants in excess of 7,993, Lilly
acknowledges and agrees that the minimum number of releases and qualified cases as set forth in
Paragraph IV(I) will not change.
2. A list of Participating Law Firms. This list was provided to Lilly and identifies the
names of the law firms participating in this Agreement.
E. SETTLEMENT FUND
1. Funding Terms and Schedule
In consideration of Participating Claimants promises, releases and other agreements as set
forth in this Agreement and because a list of at least 7,993 Participating Claimants and a list of
Participating Law Firms has been provided to Lilly, Lilly will pay $700 million (the Settlement
Amount) into a settlement fund held in escrow by Citibank, N.A., as escrow agent, the following
sums at the times stated:
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September 7, 2005:
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Lilly will pay $300 million. |
September 15, 2005:
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Lilly will pay $200 million. |
December 15, 2005:
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Lilly will pay $200 million. |
6
The settlement funds will be used as outlined below and distributed pursuant to escrow
instructions to be agreed to by the parties:
(a) $690 million for the resolution and satisfaction of the Participating Claimants claims;
and
(b) $10 million for administrative expenses, costs and services in connection with the
resolution of claims including those incurred by the Participating Law Firms and third parties in
creating the settlement fund and in setting up the procedures necessary to implement the claims
settlement process as envisioned by this Agreement.
Lilly will also pay no later than December 15, 2005 the difference between the actually
accrued interest on the settlement fund, and that amount that would have accrued had the entire
amount been deposited on July 29, 2005 (Accrued Interest). Lillys obligation to pay interest
will be fifty percent (50%) of the Accrued Interest that would have been accrued between July 29,
2005 and August 29, 2005 and 100% from August 30, 2005 and thereafter. The rate of interest shall
be based on the actual rate earned by the Citibank Institutional Market Deposit Account from
between July 29, 2005 and the date the final deposit is made by Lilly. Lilly shall have no further
responsibility for the payment of any further funds under this settlement.
Lilly further agrees that in the event that the Special Settlement Masters verify that the
claims administration process has been completed before December 15, 2005, Lilly will immediately
pay into the settlement fund any monies that would not otherwise be owed until December 15, 2005.
7
2. Establishment and Administration of Qualified Settlement Fund
The Settlement Amount is intended to be deposited into a Qualified Settlement Fund within
the meaning of Treas. Reg. Sec. 1.468B-1, which shall be designated as the Qualified Settlement
Fund A for Certain Zyprexa Products Claims (Settlement Fund). The U.S. District Court for the
Eastern District of New York has authorized the establishment of the Settlement Fund, subject to
the Courts jurisdiction. The parties agree that Citibank N.A. shall act as the escrow agent
(Escrow Agent) and Seeger Weiss LLP, acting through Christopher A. Seeger on behalf of the
Participating Law Firms shall be designated as the trustee of the Settlement Fund.
It is agreed and understood by the parties to this Agreement that Lilly accepts no
responsibility or liability for any allocation or division of the settlement fund as among the
claimants. Further Lilly and their counsel accept no responsibility for any tax liability that may
attach to the proceeds of the Settlement Fund and the Participating Claimants and Participating Law
Firms acknowledge that Lilly has not made any representations regarding the taxability or
non-taxability of such proceeds.
F. RELEASE OF FUNDS FROM THE SETTLEMENT FUND
The payment of administrative expenses, costs and services outlined above shall be released by
the Escrow Agent pursuant to written escrow instructions provided by the parties.
The payment of awards from the Settlement Fund to Participating Claimants in resolution and
satisfaction of their claims shall only be released by the Escrow Agent pursuant to written escrow
instructions to be provided by Lilly and the Participating Law Firms and subject to the following:
8
(a) Within 15 days of receipt of at least 7,193 releases and waivers required to be
provided under Paragraph IV (I) (2), and confirmation from the Special Settlement Masters that the
releases and waivers conform to the minimum requirements set forth in Paragraph IV (I), i.e. that
at least 7,193 releases are from Zyprexa users, who are U.S. residents [ * ]: (1) Lilly
shall either (i) confirm in writing to the Participating Law Firms and the Special Settlement
Masters that it has accepted the releases and waivers provided and the confirmation of the Special
Masters, or (ii) notify the Participating Law Firms and the Special Settlement Masters that the
releases and waivers received and/or the confirmation received from the Special Settlement Masters
fail to meet the requirements under this Agreement. If Lilly rejects the releases and waivers as
tendered or fails to accept the confirmation of the Special Settlement Masters, Lilly shall state
its reasons with reasonable detail and the parties shall meet and confer promptly to attempt to
resolve any dispute.
(b) If Lilly has given the confirmations called for by paragraph (a)(i) above, Lilly and
the Settlement Fund trustee shall within 10 days issue joint written escrow instructions to the
Escrow Agent to release up to $50 million from the Settlement Fund for payment to Participating
Claimants that are entitled to receive an award as determined by the Special Settlement Masters.
(c) Any and all remaining settlement funds available to satisfy awards made to Participating
Claimants shall be distributed after the Special Settlement Masters have certified by notice to the
Participating Law Firms and to Lilly that the conditions of Paragraph IV(H) and Paragraph IV(I)
have been satisfied.
* Material has been omitted pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and
Exchange Commission.
9
(d) If the confirmations called for by paragraph (c) above are issued, Lilly and the
Settlement Fund trustee shall within 5 days issue joint written instructions to the Escrow Agent to
release the balance of the funds remaining in the Settlement Fund for the payment of awards to the
Participating Claimants and/or for payment of administrative costs incurred or services provided in
connection with the creation and implementation of the claims administration process and this
settlement, as determined by the Special Settlement Masters.
Assuming the conditions of this Agreement are met, any interest which has accrued on the
Settlement Fund shall be paid as determined by the Special Settlement Masters consistent with the
applicable ethical rules in the following order: first, for administrative expenses or costs
incurred, or services provided, by Participating Law Firms and third parties for their efforts in
creating the Settlement Fund and in setting up the procedures necessary to establish and implement
the claims settlement process as envisioned by this Agreement, and second, to the Participating
Claimants on a pro-rata basis, pursuant to protocols developed by the Special Settlement Masters.
Interest accumulated in the Settlement Fund will not in anyway inure to the benefit of Lilly,
unless the conditions of this Agreement are not satisfied.
If the conditions of this Agreement are not met, all monies deposited by Lilly and any
interest accumulated into the Settlement Fund, other than any monies released for administrative
costs and expenses outlined above, shall be returned to Lilly.
Lilly shall have no further responsibility for the payment of any funds other than as outlined
above.
G. CLAIMS ADMINISTRATION
The Special Settlement Masters shall establish a claims administration process that shall
include guidelines and procedures for the administration of the settlement and the establishment
10
of
escrow accounts as may be necessary to satisfy all lienholder claims that have been or may be
asserted against Participating Claimants in connection with their use of Zyprexa.
The claims administration process shall have been completed when the Special Settlement
Masters have determined that (i) provision has been made for the payment of all administrative
expenses, costs and services, (ii) releases have been provided to Lilly for all Participating
Claimants that are eligible for awards, and (iii) the audit set forth in Paragraph IV(H) has been
completed.
H. CLAIM VERIFICATION
The Special Settlement Masters shall audit, report and confirm to Lilly that the conditions in
Paragraph IV(I) are met prior to the issuance of any award to any Participating Claimant. The
Special Settlement Masters shall provide to Lilly information on the manner in which the audit and
confirmation process was conducted in a format to be mutually agreed upon by the parties and the
Special Settlement Masters.
I. RELEASES, WAIVERS AND DISMISSALS
1. Minimum Requirement. This Agreement and the distribution of funds to Participating
Claimants are conditioned upon:
a. Lilly obtaining releases and waivers of all past, present and future claims from no fewer
than 7,193 Participating Claimants (Distribution Threshold), which number represents ninety
percent (90%) of the minimum 7,993 Participating Claimants referenced in Paragraph IV(D).
Settlement payments shall only be issued to persons who are
11
U.S. residents who took Zyprexa. The
parties agree that before any individual Participating Claimant receives a settlement payment, such
Participating Claimant must either dismiss with prejudice his or her Zyprexa-related lawsuit and
provide a waiver and release as noted below, or if no such lawsuit has been commenced, provide
Lilly with a waiver and release of all Zyprexa-related claims, whether or not asserted by the
Participating Claimant. Such dismissals and waivers shall terminate the subject lawsuit or
released claim as to all named parties in its entirety. Dismissals shall be effective as to all
named defendants, including but not limited to claims against present or former Lilly employees
involving the use and/or prescription of Zyprexa by third party defendant physicians, health care
providers, hospitals and other medical facilities.
[ * ]
2. Release Provisions. Releases of liability must be provided to Lilly by any Participating
Claimant who receives an award through the claims administration process. Such releases shall be
obtained by Lilly from no fewer than 7,193 Participating Claimants. The releases from all
Participating Claimants shall release all claims which each individual Participating Claimant ever
had, or now has, or hereafter can, shall or may have in the future against Lilly arising out of,
relating to, resulting from, or in any way connected with Zyprexa, including those claims and
damages of which the Participating Claimant is not aware and/or that Participating Claimant has not
yet anticipated and shall also extend to all named defendants in pending cases and all other third
parties as described more fully in the Confidential Individual Release attached hereto as Exhibit
A, the content of which is incorporated herein and made part
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* |
|
Material has been omitted pursuant to a request for confidential treatment. The omitted material
has been filed with the Securities and Exchange Commission. |
12
of this Agreement. The Confidential
Individual Release shall not be modified except upon written consent by Lilly.
J. DISMISSALS OF THIRD PARTIES AND SETTLEMENTS WITH THIRD PARTIES
Any dismissal of a lawsuit against Lilly shall extend to and include a dismissal with
prejudice of the entire action or claim as to all named defendants, including but not limited to
physicians, health care providers, hospitals and other medical facilities, as well as any present
or former Lilly employees.
Participating Claimants agree not to seek any settlement with any third party as to a case
subject to this Agreement. If a Participating Claimant has reached a settlement with a third party
or a named defendant in a lawsuit that is the subject of this Agreement, the fact and amount of
settlement must be disclosed to Lilly and the Special Settlement Masters. The amount of any such
settlement shall be considered by the Special Settlement Masters in making any award.
K. CLASS ACTION CLAIMANTS
The individual plaintiffs in Ortiz, et al., v. Eli Lilly and Company, No. 04-CV-1587 (JBW),
Tringali, et al., v. Eli Lilly and Company, No. 04-CV-2104 (JBW) and Dau, et al., v. Eli Lilly and
Company, No. 04-CV-4732 (JBW) currently pending in In re Zyprexa Products Liability Litigation, MDL
No. 1596, in the United States District Court for the Eastern District of New York, have decided
after consultation with their counsel that they choose to participate in the settlement process
contemplated by this Agreement and have agreed to stipulate to the dismissals of the above-stated
actions and together with Lilly will seek court approval of the
13
dismissals of such actions without
costs or fees to any party. It is acknowledged that none of the above-stated class action cases
have received class certification.
L. LIENS, ASSIGNMENT RIGHTS AND OTHER THIRD PARTY PAYOR CLAIMS
Each Participating Claimant shall identify for the Special Settlement Masters all known lien
holders, as described below, lawsuits or interventions, including by subrogation, through
procedures and protocols to be established by the Special Settlement Masters. Similarly, each
Participating Claimant shall also identify government payors, including Medicare or Medicaid liens
if they exist regardless of notice, through procedures and protocols to be established by the
Special Settlement Masters. The lien holders and parties who hold rights through statutory
assignments or otherwise (hereinafter referred to collectively as lien holders) who must be
identified are those third-party payors (public or private) that have paid for and/or reimbursed
Participating Claimants for Zyprexa and/or any drug costs, hospital expenses, medical expenses,
physician expenses or any other health care provider expenses arising from or based upon the
provision of medical care or treatment provided to the Participating Claimant in connection with
his or her claimed injury due to the use of Zyprexa. Prior to receiving his or her award, each
Participating Claimant shall represent and warrant that any liens, assignment rights, or other
claims identified above have been or will be satisfied by the Participating Claimant. Satisfaction
of any liens, assignments, or other claims as identified above is the sole responsibility of the
Participating Claimant and his or her attorney and must be established to the satisfaction of the
Special Settlement Masters, which may include an agreement to compromise any such liens, before
settlement funds can be disbursed. Upon request to the Special Settlement Masters, Lilly
14
shall be
entitled to proof of lien or claim satisfaction and/or payment of such for each Participating
Claimant for liens arising from or in connection with their use of Zyprexa.
Participating Claimants hereinafter agree under this Agreement that they are releasing Lilly
from all future medical expenses, including but not limited to drug costs, hospital, medical,
physician or health care provider expenses relating to any past, present or future medical care or
treatment arising from or in connection with the use of Zyprexa.
M. INDEMNITY
Participating Claimants agree to indemnify and defend Lilly against and hold Lilly harmless
from any and all damages or losses Lilly may incur, including attorneys fees and costs, in
connection with: (i) claims or actions seeking damages for or attributable to the personal injuries
and/or death, specific to any Participating Claimant allegedly related in any way to Zyprexa,
including without limitation, any such claim or action by any potential claimant under applicable
law, including the Participating Claimants heirs, surviving spouse, (including a putative or
common law spouse), surviving domestic partner, next of kin, successors, assigns, agents,
representatives, guardians, duly-appointed trustees, executors, estate administrators or personal
representatives (or equivalent thereto), and (ii) liens, assignments, subrogated interests,
encumbrances, causes of action, suits or judgment asserted by lien holders as defined in Paragraph
L above specific to a Participating Claimants claims for drug costs, hospital, medical, physician
or health care provider expenses spent for medical care or treatment to any Participating Claimant
arising from or in connection with their use of Zyprexa.
15
N. NO ADMISSION OF LIABILITY
This Agreement is entered into solely by way of compromise and settlement and is not and shall
not be construed as an admission of liability, responsibility or fault of or by Lilly.
O. RETURN OF CONFIDENTIAL DOCUMENTS
The parties acknowledge that Lilly has entered into a protective order with each Participating
Law Firm and that Lilly intends to enforce and the Participating Law Firms intend to abide by the
protective orders while the Participating Law Firms and Lilly are working towards meeting the
conditions of this Agreement. Further, all documents produced by Lilly or any third party and
that have been designated as Confidential or protected under any Protective Order in any pending
Participating Claimant case resolved pursuant to this Agreement shall be returned to Lilly pursuant
to the provisions of the applicable Protective Orders, unless otherwise directed by an order of the
Court in MDL No. 1596, which order shall be controlling. Notwithstanding the generality of the
foregoing, in no event shall any Participating Claimant be required to return any medical records
or other document(s) pertaining specifically to such Participating Claimant.
The parties acknowledge that each Participating Law Firms obligation to comply with the
provisions of any applicable protective order concerning confidential documents does not supersede
any existing law and may be modified by order of the Court in MDL No. 1596, which order shall be
controlling.
16
P. CONFIDENTIALITY
1. Confidentiality Agreement. The terms of this Agreement and the amount of settlement awards
made to Participating Claimants under this Agreement are confidential, except as may be required by
law and then only to the extent necessary. Any and all evaluation processes and procedures utilized
in conjunction with the claims administration or award distribution process shall also be kept
strictly confidential among the Participating Claimants and the Participating Law Firms.
Agreement to, and maintenance of, confidentiality are material terms of this Agreement. It is
agreed that the following language shall be included in individual settlement releases and is
incorporated in this Agreement:
Participating Claimant and his/her attorneys shall keep strictly confidential and agree not
to publicize, disclose or characterize to any third party, person or entity, at any time,
the following information, except as it may otherwise appear in the public domain:
Memorandum of Understanding dated June 8, 2005, the Confidential Settlement Agreement and
Release and any of the terms and conditions of this settlement, the amount of this
settlement, the history, background and/or substance of the negotiations, directly or
indirectly, leading up to this Settlement Agreement, or any other information which would
assist a third party in receiving or otherwise learning about this Confidential Settlement
Agreement and Release, and such terms, conditions, amounts, history, background and/or the
substance of any such negotiations (all which shall be and is Confidential Information),
except as required by any law. Participating Claimant and his/her attorneys may, however,
make disclosure of the money received by Participating Claimant to their accountants and/or
financial advisors who shall, however, upon such
17
disclosure, be instructed to maintain and
honor the confidentiality of such information. If inquiry is made by any third person
concerning the status of Participating Claimants lawsuit, other than as identified above
and as necessary to resolve the liens identified above, Participating Claimant and his/her
attorneys shall respond only that the suit has been resolved, and make no further comments.
Participating Claimants and his/her attorneys further agree not to communicate, publish
or cause to be published, in any public or business forum or context, any statement, whether
written or oral, concerning the specific events, facts or circumstances giving rise to a
Participating Claimants claims. The parties agree that any violations of the
confidentiality provisions of this Settlement Agreement shall entitle the non-breaching
party to bring an action against the breaching party to seek and recover immediate relief,
redress and damages associated with such breach, including injunctive relief, as may be
proven.
2. Inadmissibility of Settlement and Related Documents. Participating Law Firms, and
Participating Claimants who receive awards pursuant to this Agreement, shall not offer in evidence
or in any way refer to in any civil, criminal, administrative or other related action or
proceeding, the Memorandum of Understanding dated June 8, 2005 and any addendum thereto, this
Agreement, its terms or any Confidential Discovery Materials as defined in Case Management Order
No. 3 (protective order) filed on August 9, 2004 in MDL No. 1596, or in any other protective order
issued in any pending case, other than as may be necessary to consummate or enforce this Agreement.
If the subject of the MOU, this Agreement, its terms or any Confidential Discovery Materials shall
arise in any such legal proceedings, Participating
18
Claimants and Participating Law Firms shall, to
the extent possible, 1) oppose disclosure, 2) give Lilly notice and an opportunity to intervene and
oppose disclosure, 3) file under seal any documents disclosing this Agreement, its terms or any
Confidential Discovery Materials, and 4) take reasonable measures to ensure that this Agreement,
its terms and any Confidential Discovery Material are kept confidential and that any disclosure
thereof takes place in camera. In the event that there is a proceeding to consummate or enforce
this Agreement, including but not limited to any proceeding involving a minors compromise, death
compromise, divorce or any other judicial proceeding, Participating Claimant will file under seal
any documents which disclose or refer to this Agreement, its terms or any Confidential Discovery
Materials, will conduct all related proceedings under seal, and will take reasonable measures to
ensure that this Agreement, its terms and any Confidential Discovery Materials are kept
confidential and that any disclosure thereof takes place in camera.
The above agreements shall be null and void, assuming the conditions of this Agreement are not
met and Lilly elects not to go forward with this settlement.
Q. SUCCESSORS AND ASSIGNS.
The terms and conditions of this Agreement shall inure to the benefit of and be binding upon
the respective successors and assigns of each party hereto.
R. GOVERNING LAW
This Agreement shall be governed by and construed in accordance with the laws of Indiana
without regard to choice of law principles.
19
S. CHALLENGES TO OR DISPUTES INVOLVING THIS AGREEMENT
Any challenges to or disputes arising out of or relating to an alleged violation of this
Agreement, including but not limited to disputes between Lilly and Participating Law Firms and/or
Participating Claimants and disputes between or among Participating Law Firms and/or members of
Participating Law Firms arising out of or in connection with this Agreement, shall be referred for
binding determination to Judicial Arbitration Mediation Services (JAMS) for resolution. The
parties shall work together to agree on a binding neutral arbitrator to resolve any and all
disputes and if an agreed upon arbitrator can not be selected, JAMS complex resolution procedures
shall control the selection of a neutral arbitrator.
T. ATTORNEYS FEES
Nothing in this Agreement shall affect the obligation of any Participating Claimant to pay
attorneys fees and costs pursuant to any agreement such Participating Claimant may have with his
or her counsel. Lilly shall have no responsibility whatsoever for the payment of Participating
Claimants attorneys fees. Any division of the Settlement Amount is to be determined by
Participating Claimant and Participating Law Firms and shall in no way affect the validity of this
Agreement or the Confidential Individual Release executed by any Participating Claimant.
U. MERGER AND INTEGRATION
This Agreement supersedes and replaces any prior agreement, tolling agreement or writing
between the parties and constitutes the entire Agreement between Lilly, the Participating Law Firms
and the Participating Claimants.
20
V. NOTICE
Any notices required under this Agreement shall be provided as follows:
(a) For the Participating Law Firms, notice shall be provided to:
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Christopher A. Seeger
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Thomas A. Schultz |
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Seeger Weiss LLP
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Lopez, Hodes, Restaino, Milman & Skikos |
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One William Street
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450 Newport Center Drive, Second Floor |
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New York, NY 10004
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Newport Beach, CA 92660 |
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212-584-0700 (phone)
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949-640-8222 (phone) |
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212-584-0799 (fax)
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949-640-8294 (fax) |
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cseeger@seegerweiss.com
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tschultz@lopez-hodes.com |
(b) For Lilly, notice shall be provided to:
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Nina M. Gussack |
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Pepper Hamilton LLP |
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3000 Two Logan Square |
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Philadelphia, PA 19103 |
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215-981-4950 (phone) |
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215-981-4307 (fax) |
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gussackn@pepperlaw.com |
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(c) For the Special Settlement Masters, notice shall be provided to:
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Honorable John B. Trotter (retired)
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Catherine Yanni |
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JAMS
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JAMS |
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500 N. State College Blvd., Ste. 600
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Two Embarcadero Center, Ste. 1100 |
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Orange, CA 92868
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San Francisco, CA 94111 |
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714-939-1300 (phone)
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415-982-5267 (phone) |
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714-939-8710 (fax)
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415-527-9611 (fax) |
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tlunceford@jamsadr.com
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cayanni@comcast.net |
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Kenneth Feinberg |
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Michael Rozen |
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The Feinberg Group |
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780 Third Avenue, 26th Floor |
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New York, NY 10017-2024 |
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212-527-9600 (phone) |
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212-527-9611 |
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rsrosen@feinberggroup.com |
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(d) For the escrow agent, notice shall be provided to:
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Kerry M. McDonough, Vice President |
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The Citigroup Private Bank |
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Preferred Custody Services |
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120 Broadway, 2nd Floor |
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New York, NY 10271 |
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212-804-5499 (phone) |
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212-804-5401 (fax) |
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Executed on ___, 2005.
21
SO AGREED ON BEHALF OF THE PARTICIPATING CLAIMANTS AND THE PARTICIPATING LAW FIRMS:
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Melvyn I. Weiss
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Ramon Rossi Lopez |
Milberg Weiss Bershad & Schulman LLP
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Lopez, Hodes, Restaino, Milman & Skikos |
One Pennsylvania Plaza, 49th Floor
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450 Newport Center Drive, Second Floor |
New York, NY 10119
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Newport Beach, CA 92660 |
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Christopher A. Seeger
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Nancy Hersh |
Seeger Weiss LLP
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Hersh & Hersh |
One William Street
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601 Van Ness Avenue, Suite 2080 |
New York, NY 10004
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San Francisco, CA 94102 |
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H. Blair Hahn
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Mark Robinson |
Richardson, Patrick, Westbrook & Brickman LLC
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Robinson, Calcagnie & Robinson |
1037 Chuck Dawley Blvd., Bldg. A
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620 Newport Center Drive, 7th Floor |
Mt. Pleasant, SC 29464
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Newport Beach, CA 92660 |
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Jerrold S. Parker
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Perry Weitz |
Parker & Waichman
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Weitz & Luxenberg |
111 Great Neck Road
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180 Maiden Lane |
Great Neck, NY 11021
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New York, NY 10038 |
22
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Michael Heaviside
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Michael A. London |
Ashcraft & Gerel
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Douglas & London |
2000 L Street, N.W., Suite 400
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111 John Street, 8th Floor |
Washington, D.C. 20036
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New York, NY 10038 |
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Troy Rafferty
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Michael Burg |
Levin Papantonio Thomas Mitchell
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Burg Simpson Eldredge Hersh & Jardine PC |
Echsner & Proctor PA
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40 Inverness Drive East |
316 South Baylen Street, Suite 600
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Englewood, CO 80112 |
Pensacola, FL 32502 |
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Tommy Fibich
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Scott Levensten |
Fibich, Hampton, Leebron & Garth
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The Beasley Firm |
Five Houston Center
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1125 Walnut Street |
1401 McKinney, Suite 1800
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Philadelphia, PA 19107 |
Houston, TX 77010 |
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Dennis Reich
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Michael Schmidt |
Reich & Binstock
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The Schmidt Law Firm |
4265 San Felipe, Suite 100
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8401 North Central Expressway, Suite 880 |
Houston, TX 77027
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Dallas, TX 75225 |
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Ron
Meneo
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Early
& Meneo, LLP
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One
Century Tower
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265
Church Street
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New
Haven, CT 06508-1806
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SO AGREED ON BEHALF OF ELI LILLY AND COMPANY:
23
|
|
|
|
|
|
Nina M. Gussack
|
|
Colleen T. Davies |
Pepper Hamilton LLP
|
|
Reed Smith LLP |
3000 Two Logan Square
|
|
1999 Harrison Street |
Philadelphia, PA 19103
|
|
Suite 2400 |
|
|
Oakland, CA 94612 |
|
|
|
|
|
|
George Lehner
|
|
Steven M. Kohn |
Pepper Hamilton
|
|
Reed Smith LLP |
600 14th Street N.W.
|
|
1999 Harrison Street, Suite 2400 |
Washington, D.C. 20005
|
|
Oakland, CA 94612 |
24
DRAFT EXEMPLAR EXHIBIT A
Claimant
Name:
SSN:
Address:
Claimant No.
CONFIDENTIALITY RELEASE OF ALL CLAIMS
v. ELI LILLY AND COMPANY
This Confidential Individual Settlement Agreement and Release of All Claims (hereinafter the
Confidential Release) is entered into between individually and on
behalf of all derivative claimants under applicable law, (hereinafter defined directly below as
Claimant) and Eli Lilly and Company (hereinafter Lilly as further defined below). This
Confidential Release is deemed effective as of (the Effective Date).
DEFINITIONS
Claimant as used and referred to in this Confidential Release shall include
and all other derivative claimants under applicable law, including but not limited to the
Claimants heirs, surviving spouse (including a putative or common law spouse), surviving
domestic partner, next of kin, successors, assigns, agents, representatives, guardians,
duly-appointed trustees, executors, estate administrators or personal representatives (or the
equivalent thereto).
Claimants Counsel as used and referred to in this Confidential Release shall include the
following attorney(s) and law firm(s): and all attorneys and
members of the firm, as well as associate and co-counsel and all other attorneys who have
rendered legal services on behalf of the Claimant in pursuit of the Claimants claim.
Lilly as used and referred to in this Confidential Release shall include Eli Lilly and Company,
a corporation, and the entire company, its officers, directors, employees and shareholders, and its
past, present and future parents, subsidiaries, affiliates, controlling persons, suppliers,
distributors, contractors, agents, assigns, servants, counsel and insurers, and all of their
officers,
directors, employees, shareholders, predecessors, successors, assigns, heirs, executors, estate
administrators or personal representatives (or the equivalent thereto).
Master Settlement Agreement as used and referred to in this Confidential Release refers to the
Master Settlement Agreement dated September 16, 2005 entered into between Lilly and certain
plaintiffs counsel representing Zyprexa claimants, including all plaintiffs counsel who are
members of the Plaintiffs Steering Committee (PSC) appointed in In re Zyprexa® Products
Liability Litigation, MDL No. 1596, in the United States District Court for the Eastern District of
DRAFT EXEMPLAR EXHIBIT A
New York and other plaintiffs counsel, defined in the Master Settlement Agreement as the
Participating Law Firms.
Special Settlement Masters as used and referred to in this Confidential Release refers to the
Special Settlement Masters who were appointed by Case Management Order 12 to assist in the
claims administration process described in the Master Settlement Agreement.
RECITALS
A. |
|
Claimant has either filed an action alleging injury and damages associated with the use of
Zyprexa or has provided Lilly with notice of a claim, alleging damages associated with
the use of Zyprexa by way of a tolled claim subject to a Tolling Agreement between the
Claimant and Lilly and/or by way of a claim asserted informally by way of his/her
participation in the settlement process as outlined below.
|
|
|
|
Lilly disputes any and all allegations by the Claimant and denies that it has any liability
with respect to these claims. |
|
B. |
|
On September 16, 2005, a Master Settlement Agreement was entered into as described
above. |
|
C. |
|
In connection with that Master Settlement Agreement, Claimant was identified and
included as a Participating Claimant. In addition, a claims administration process has
been established pursuant to the Master Settlement Agreement. |
|
D. |
|
Each of the following conditions must be satisfied under the Master Settlement
Agreement before a monetary payment can be made under this Confidential Release: |
|
1. |
|
The Special Settlement Masters have audited, reported and confirmed to Lilly that
the conditions in Paragraph IV(I) of the Master Settlement Agreement have been
met, specifically, that there are at least
[ ] claimants who have released their
claims and that of those released claimants at least
[ ] claimants have a
diabetes-related injury pursuant to the criteria and protocols established by the
Special Settlement Masters. |
|
|
2. |
|
The Special Settlement Masters have provided to Lilly information as required by
Paragraph IV(H) of the Master Settlement Agreement concerning the manner in
which they performed the audit and confirmation process to satisfy that the
conditions in Paragraph IV(I). |
|
|
3. |
|
The Special Settlement Masters have confirmed that Claimant used Zyprexa, that
the Claimant is a U.S. resident and that the Claimant has a compensable injury
under the claims administration process. |
|
|
4. |
|
Finally, satisfaction of liens, assignment rights or other third party claims
identified under Paragraph 6 of this Confidential Release has been or will be
satisfied by the Claimant or an appropriate hold-back order will be issued
pursuant to protocols established by the Special Settlement Masters. |
DRAFT EXEMPLAR EXHIBIT A
E. |
|
As such, Claimant and Lilly have reached a settlement and resolution of all actual or
potential disputes that have arisen between them relating to Claimants use of Zyprexa in
accordance with this Confidential Release. |
AGREEMENT
1. |
|
Basic Agreement |
|
|
|
For and in consideration of a release of all past, existing, and future claims relating to
Zyprexa, whether known or unknown, and other agreements as set forth herein, and in
complete settlement of the cases and claims asserted by Claimant, Lilly hereby agrees to
make payment to Claimant as described below. |
|
2. |
|
Settlement Amount |
|
|
|
In consideration of Claimants promises, releases and other agreements as set forth in this
Confidential Release, Claimant and Claimants Counsel shall be paid a minimum of
, based on the proof submitted by the Claimant to the Special
Settlement Masters. The Ultimate Settlement Amount will be determined by the Special
Settlement Masters through the claims administration process based on the materials
submitted by the Claimant and their counsel and as ultimately evaluated and determined
by the Special Settlement Masters, provided that such amount will not be less than the
amount specified above. The Special Settlement Masters are hereby authorized to hold
back sums from the Settlement Amount, pursuant to written protocols developed by the
Special Settlement Masters and the Participating Law Firms, for the satisfaction of any
liens, assignments or third party claims as set forth in Paragraph 6 below of this
Confidential Release. |
|
|
|
Through the procedures, protocols and Claims Form established by the Special
Settlement Masters, Claimant has elected and agreed to a) submit his/her claim to the
claims administration process; b) to fully and finally accept the Settlement Agreement
Amount to be determined by the Special Settlement Masters; and c) to waive any right to
challenge or dispute the Special Settlement Masters final award, except as provided in
Paragraph 15 below. Copies of the Claimants Claim Form reflecting such election and
agreement, as well as the final award determination made by the Special Settlement
Master, are incorporated herein as though set forth in full. |
|
|
|
Payment of the Settlement Amount shall be made to the Claimant and Claimants
Counsel from the Settlement Fund established by the Master Settlement Agreement.
Payment shall be made only after Lilly receives from Claimant a fully executed original
of this Confidential Release and after the Special Masters certify that liens, assignments
or other third party claims, if any, set forth in Paragraph 6 of the Confidential Agreement
have been or will be satisfied by the Claimant or an appropriate hold-back order issued
pursuant to protocols established by the Special Settlement Masters. Claimant agrees that
payment of the Settlement Amount constitutes full compensation and settlement for any
and all claims identified and released under the terms of Paragraph 3 below. Claimant |
DRAFT EXEMPLAR EXHIBIT A
agrees not to seek anything further from Lilly or any other person or entity, including any
other payment, in regard to such claims.
Lilly accepts no responsibility or liability for an allocation or division of the Settlement
Amount.
Further, neither Lilly, their counsel nor Claimants counsel accepts responsibility for any
tax liability or adverse effect on third party benefits received by the Claimant, if any,
arising out of the receipt of these settlement proceeds, and the Claimant acknowledges
that neither Lilly, their counsel or Claimants counsel has made representations regarding
the taxability or non-taxability or the effect on Claimants receipt of third party benefits
as a result of Claimants receipt of these settlement proceeds.
3. |
|
Release |
|
|
|
In consideration of the payment of the Settlement Amount, Claimant releases, acquits,
forever discharges and covenants not to sue as to all claims which Claimant ever had, or
now has, or hereafter can, shall or may have in the future against Lilly arising out of,
relating to, resulting from, or in any way connected with Zyprexa, including those claims
and damages of which the Claimant is not aware and/or that Claimant has not yet
anticipated. |
|
|
|
This Confidential Release includes, but is not limited to, any and all past, present and
future claims, whether known or unknown, arising out of, relating to, resulting from, or in
any way connected with the use of Zyprexa and any alleged defect or failure of Zyprexa,
including without limitation, any claims for damages, wrongful death, personal injury,
emotional distress, pain and suffering, loss of society and companionship, loss of income,
loss of consortium, medical expenses, future cost of insured services, past cost of insured
services, punitive damages, or any other form of damages whatsoever. |
|
|
|
In addition to Lilly, this release extends to all named defendants in pending litigation and
all other third parties in any way connected with Claimants use of Zyprexa, including
without limitation, physicians, health care providers, hospitals, pharmacies and other
medical facilities, their past, present and future parents, subsidiaries, affiliates,
controlling persons, suppliers, distributors, contractors, agents, assigns, servants, counsel
and insurers, and all of their past, present and future officers, directors, employees,
shareholders, predecessors, successors, assigns, heirs, executors, estate administrators or
personal representatives (or the equivalent thereto). |
|
|
|
Acknowledgement Concerning Release of Unknown and Future
Claims.1 Claimant
expressly waives the provisions of any applicable law protecting against the release of |
|
|
|
1 |
|
This Confidential Release will be modified to include any applicable state law
provisions. This will
include but not be limited to provisions with regard to the acknowledgement of Claimants agreement
to
waive unknown and future claims. For example, in California the Confidential Release shall include
the
following language: The provisions of Section 1542 of the Civil Code of the State of California are
hereby
expressly waived and Claimant understands that said section provides: A general release does not
extend
to claims which the creditor does not know or suspect to exist in his or her favor at the time of
executing |
(continued...)
DRAFT EXEMPLAR EXHIBIT A
unknown or unanticipated claims. Claimant understands and acknowledges the
significance and consequences of releasing all of the Zyprexa-related causes of action
and/or claims (including presenting existing, but unknown, unasserted, unsuspected, or
undiscovered Zyprexa-related causes of action and/or claims), including but not limited
to diabetes-related causes of action and/or claims, and hereby assumes full risk and
responsibility for any and all injuries, losses, damages, assessments, penalties, charges,
expenses, costs, and/or liabilities that Claimant may hereinafter incur or discover that in
any way arise out of or relate to such causes of action and/or claims. To the extent that
any law, statute, ordinance, rule, regulation, case or other such legal provision or
authority may purport to preserve the Claimants right hereafter to assert presently
existing but unknown, unasserted, unsuspected, or undiscovered Zyprexa-related and
diabetes-related causes of action and/or claims, which would otherwise be barred by the
terms of this Release, Claimant hereby specifically and expressly waives Claimants
rights under such law, statute, ordinance, rule, regulation, case or other such legal
provision or authority.
Claimant understands and acknowledges the significance and consequence of releasing
all such claims, including all future claims, whether known or unknown. In this regard,
Claimant has been fully advised of Claimants legal rights by counsel, and hereby
assumes full risk and responsibility for any and all injuries, losses, damages, assessments,
penalties, charges, expenses, costs, and/or liabilities that Claimant may hereafter incur or
discover which in any way arise out of or relate to such claims. Claimant further
acknowledges having obtained or having been advised of his/her right to seek
independent legal advice related to the waiver of these claims.
4. |
|
Dismissal of Action And Promise Not to Sue or Bring Future Claims
|
|
|
|
|
|
In consideration of payment of the Settlement Amount by Lilly, Claimant shall dismiss
all filed claims, if any, arising out of the use of Zyprexa currently pending in any court or
other tribunal, with prejudice, and without costs or fees to any party. Claimant authorizes
and instructs his/her counsel to immediately deliver to Lillys counsel a Notice of
Dismissal with prejudice as against all defendants in accordance with the provisions of
this Confidential Release. This dismissal shall extend to and include a dismissal with
prejudice of the entire action or claim as to all named defendants, including but not
limited to physicians, health care providers, hospitals and other medical facilities, as well
as any present or former Lilly employees.
|
|
|
|
|
|
Claimant further promises and agrees that in consideration of payment of the Settlement
Amount by Lilly, that Claimant never will file, maintain or prosecute any suit or action at
law or in equity against Lilly in any court, state or federal, of the United States of |
(continued...)
the release, which if known by him or her must have materially affected his or her settlement with
the
debtor.
DRAFT EXEMPLAR EXHIBIT A
America or elsewhere in the world, arising out of or by reason of or in any manner
associated with Claimants use of Zyprexa.
5. |
|
Settlements |
|
|
|
Claimant agrees not to seek any settlement with a third party arising out of the use of
Zyprexa. Furthermore, if any such settlement has occurred, Claimant warrants and
represents that he or she has disclosed to Lilly and to the Special Settlement Masters the
fact and amount of any such settlement, so that the amount of any such settlement is
considered by the Special Settlement Masters in making any award to Claimant. |
|
6. |
|
Liens, Assignment Rights and Other Third Party Payor Claims |
|
|
|
Claimant represents and warrants that all known lien holders, as described below,
lawsuits or interventions, including by subrogation, have been identified through
procedures and protocols established by the Special Settlement Masters. Claimant further
represents and warrants that Claimant has also identified government payors, including
Medicare or Medicaid liens if they exist regardless of notice, through procedures and
protocols established by the Special Settlement Masters. The lien holders and parties
who hold rights through statutory assignments or otherwise (hereinafter referred to
collectively as lien holders) who must be and have been identified are those third-party
payors (public or private) that have paid for and/or reimbursed Claimants for Zyprexa
and/or any drug costs, hospital expenses, medical expenses, physician expenses or any
other health care provider expenses arising from or based upon the provision of medical
care or treatment provided to the Claimant in connection with his or her claimed injury
due to the use of Zyprexa. Claimant represents and warrants prior to receiving his or her
award that any liens, assignment rights, or other claims identified above have been or will
be satisfied by the Claimant. Satisfaction of any liens, assignments, or other claims as
identified above is the sole responsibility of the Claimant and his or her attorney and
must be established to the satisfaction of the Special Settlement Masters, which may
include an agreement to compromise any such liens before settlement funds can be
disbursed. |
|
|
|
Claimant understands that upon request to the Special Settlement Masters, Lilly shall be
entitled to proof of Claimants lien or claim satisfaction and/or payment of liens arising
from or in connection with Claimants use of Zyprexa. |
|
|
|
Claimant hereinafter agrees that Claimant is releasing Lilly from all future medical
expenses, including but not limited to drug costs, hospital, medical, physician or health
care provider expenses relating to any past, present or future medical care or treatment
arising from or in connection with Claimants use of Zyprexa. |
|
7. |
|
Indemnification |
|
|
|
Claimant agrees to indemnify and defend Lilly against and hold Lilly harmless from any
and all damages or losses Lilly may incur, including attorneys fees and costs, in
connection with: (i) claims or actions seeking damages for or attributable to the personal
injuries and/or death, specific to Claimant and allegedly related in any way to Zyprexa, |
DRAFT EXEMPLAR EXHIBIT A
including without limitation, any such claim or action by any potential claimant under
applicable law, including the Claimants heirs, surviving spouse, (including a putative or
common law spouse), surviving domestic partner, next of kin, successors, assigns, agents,
representatives, guardians, duly-appointed trustees, executors, estate administrators or
personal representatives (or equivalent thereto), and (ii) liens, assignments, subrogated
interests, encumbrances, causes of action, suits of judgment asserted by lien holders as
defined in Paragraph 6 of this Confidential Release, specific to Claimants claims for
drug costs, hospital, medical, physician or health care provider expenses spent for
medical care or treatment to Claimant arising from or in connection with Claimants use
of Zyprexa.
8. |
|
No Admission of Liability |
|
|
|
This Confidential Release is entered into solely by way of compromise and settlement
and is not and shall not be construed as an admission of liability, responsibility or fault of
or by Lilly. |
|
9. |
|
Warranty of Authority and Capacity |
|
|
|
Claimant represents and warrants that Claimant has full authority and capacity to enter
into this Confidential Release. |
|
10. |
|
Entire Agreement |
|
|
|
This Confidential Release contains the entire understanding of the parties regarding the
subject matter hereof. Such Agreement shall not be amended, supplemented or abrogated
other than by a written instrument signed by the authorized representatives of each party
to this Individual Settlement Agreement and Release. |
|
11. |
|
Confidentiality |
1. Confidentiality Agreement The Settlement Amount and the terms of this
Confidential Release are confidential, except as may be required by law and then only to
the extent necessary. Any and all evaluation processes and procedures utilized in
conjunction with the claims administration or award distribution process shall also be
kept strictly confidential by the Claimant and his/her attorneys.
Agreement to, and maintenance of, confidentiality are material terms of this Confidential
Release. This Confidential Release shall be null and void if the following confidentiality
conditions of this Confidential Release are not met:
Claimant and his/her attorneys shall keep strictly confidential and agree not to
publicize, disclose or characterize to any third party, person or entity, at any time,
the following information, except as it may otherwise appear in the public
domain: Memorandum of Understanding dated June 8, 2005, the Confidential
Master Settlement Agreement and this Confidential Release and any of the terms
and conditions of this settlement, the amount of this settlement, the history,
background and/or substance of the negotiations, directly or indirectly, leading up
DRAFT EXEMPLAR EXHIBIT A
to the Master Settlement Agreement and this Confidential Release, or any other
information which would assist a third party in receiving or otherwise learning
about the Confidential Master Settlement Agreement and Confidential Release,
and such terms, conditions, amounts, history, background and/or the substance of
any such negotiations (all which shall be and is Confidential Information),
except as required by any law. Claimant and his/her attorneys may, however,
make disclosure of the money received by Claimant and his/her accountants
and/or financial advisors who shall, however, upon such disclosure, be instructed
to maintain and honor the confidentiality of such information. If inquiry is made
by any third person concerning the status of Claimants lawsuit, other than as
identified above and as necessary to resolve the liens identified above, Claimant
and his/her attorneys shall respond only that the suit has been resolved, and make
no further comments.
Claimants and his/her attorneys further agree not to communicate, publish or
cause to be published, in any public or business forum or context, any statement,
whether written or oral, concerning the specific events, facts of circumstances
giving rise to Claimants claims. The parties agree that any violations of the
confidentiality provisions of this Confidential Release shall entitle the
non-breaching party to bring an action against the breaching party to seek and
recover immediate relief, redress and damages associated with such breach,
including injunctive relief, as may be proven.
2. Inadmissibility of Settlement and Related Documents. Claimants and his/her
attorneys shall not offer in evidence or in any civil, criminal, administrative or other
action or proceeding, this Confidential Release, its terms, the Memorandum of
Understanding dated June 8, 2005 and any addendum thereto, the Master Settlement
Agreement, its terms of any Confidential Discovery Materials as defined in Case
Management Order No. 3 (Protective Order), filed on August 9, 2004 in MDL No. 1596,
or in any other protective order issued in any pending case, other than as may be
necessary to consummate or enforce this Confidential Release. If the subject of this
Confidential Release, its terms, the Memorandum of Understanding dated June 8, 2005
and any addendum thereto, the Master Settlement Agreement, its terms or any
Confidential Discovery Materials shall arise in any such legal proceedings, Claimant and
his/her attorneys shall, to the extent possible, 1) oppose disclosure, 2) give Lilly notice
and an opportunity to intervene and oppose disclosure, 3) file under seal any documents
disclosing this Confidential Release, its terms, the Master Settlement Agreement, its
terms or any Confidential Discovery Materials, and 4) take reasonable measures to ensure
that this Confidential Release, its terms, the Master Settlement Agreement, its terms and
any Confidential Discovery Material are kept confidential and that any disclosure thereof
takes place in camera. In the event that there is a proceeding to consummate or enforce
this Confidential Release, the Master Settlement Agreement, including but not limited to
any proceeding involving a minors compromise, death compromise, divorce or any other
judicial proceeding, Claimant will file under seal any documents which disclose or refer
to this Confidential Release, its terms the Master Settlement Agreement, its terms or any
Confidential Discovery Materials, will conduct all related proceedings under seal, and
will take reasonable measures to ensure that this Confidential Release, its terms the
DRAFT EXEMPLAR EXHIBIT A
Master Settlement Agreement, its terms and any Confidential Discovery Materials are
kept confidential and that any disclosure thereof takes place in camera.
12. |
|
Successors and Assigns |
|
|
|
The terms and conditions of this Confidential Release shall inure to the benefit of and be
binding upon the respective successors and assigns of each party hereto. |
|
13. |
|
Governing Law |
|
|
|
This Confidential Release shall be governed by and construed in accordance with the
laws of Indiana without regard to choice of law principles. |
|
14. |
|
No Assignment/Authority |
|
|
|
Claimant represents that he/she has not assigned any interest in any of the causes of
action and/or claims released herein or if so, has identified such an assignment to the
Special Settlement Masters as required by Section 6 above. Claimant represents that
he/she collectively has the right and exclusive authority to pursue and settle the released
causes of action and/or claims. Claimant further represents that to the extent required
under the applicable law, he/she has given adequate notice to all relevant parties, and/or
sought and/or obtained judicial approval of this Confidential Release. |
|
15. |
|
Challenges To Or Disputes Involving This Agreement |
|
|
|
Any challenge or dispute arising out of or relating to an alleged violation of this
Confidential Release shall be referred for binding determination to Judicial Arbitration
Mediation Services (JAMS) for resolution. The parties shall work together to agree on
a biding neutral arbitrator to resolve any and all disputes and if an agreed upon arbitrator
can not be selected, JAMS complex resolution procedures shall control the selection of a
neutral arbitrator. |
|
|
|
In the event that a lawsuit is filed alleging a violation of this Confidential Release,
including but not limited to any allegation of a breach of the Confidentiality provisions,
the recoverable damages shall include, but not be limited to, the reasonable attorneys
fees and costs of the prevailing party. |
|
|
|
By executing this Confidential Release, Claimant understands and agrees that he/she is
submitting to the exclusive and binding jurisdiction of the Special Settlement Masters,
including whether Claimant is entitled to compensation under this settlement program
and in what amount. |
|
|
|
Further, Claimant and Claimants Counsel agree that any dispute between or among
Claimants, a Claimant and Claimants Counsel, Claimants Counsel or the Special
Settlement Masters and Claimant and/or Claimants Counsel shall also be within the
exclusive and binding jurisdiction of the Special Settlement Masters. |
|
16. |
|
Medical Documentation Authorization |
DRAFT EXEMPLAR EXHIBIT A
Claimant has authorized his/her counsel to obtain and supply to the Special Settlement
Masters and Lilly the medical or other documentation required for approval of an award
by the Special Settlement Masters under the Claims Administration process.
17. |
|
Counterparts |
|
|
|
This Confidential Release may be executed in one or more counterparts by each party to
this Confidential Release, each of which shall be deemed to be an original and all of
which taken together shall constitute one and the same Confidential Release. |
|
18. |
|
Advice of Counsel |
|
|
|
Claimant hereby acknowledges that he/she has read this Confidential Release and has had
an opportunity to obtain advice of counsel regarding it. Claimant hereby also
acknowledges that he/she understands the terms of this Confidential Release, and that
he/she freely and voluntarily signs and enters into it. Claimant further acknowledges
that, in entering into Confidential Release, he/she has not relied upon any statement or
representation by or on behalf of Lilly except as stated herein. |
|
19. |
|
Attorney Fee Disputes |
|
|
|
Nothing in this Confidential Release shall affect the obligation of the Claimant to pay
attorneys fees and costs pursuant to any agreement Claimant may have with Claimants
counsel. Lilly shall have no responsibility whatsoever for payment of Claimants
attorneys fees. Any division of the Settlement Amount is to be determined by Claimant
and Claimants Counsel and shall in no way affect the validity of this Confidential
Release. |
DRAFT EXEMPLAR EXHIBIT A
20. |
|
Enforceability |
|
|
|
In case any provision (or any party of any provision) contained in this Confidential
Release shall for any reason be held to be invalid, illegal, or unenforceable in any respect,
such invalidity, illegality, or unenforceability shall not affect any other provision (or
remaining part of the affected provision) of this Confidential Release, but this
Confidential Release shall be construed as if such invalid, illegal or unenforceable
provision (or any part thereof), had never been contained herein, but only to the extent it
is invalid, illegal or unenforceable. |
|
|
|
|
|
, individually, and on behalf of all
derivative claimants under applicable law
|
|
|
|
DATED |
I, , hereby also represent and declare that Claimant,
has at all relevant times, been represented by Claimants Counsel. Claimants Counsel have
provided Claimant a copy of the Confidential Release, and Claimants Counsel have made
themselves available to answer any and all questions with respect to the substance of the
Confidential Release. Having had a full opportunity to read, understand, and inquire of their
counsel about the terms and conditions of the Confidential Release, neither Claimant nor
Claimants Counsel has an objection to the terms of this Confidential Release.
exv11
EXHIBIT 11. STATEMENT RE: COMPUTATION OF EARNINGS (LOSS) PER SHARE
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars and shares in millions except per-share data) |
|
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
822.0 |
|
|
$ |
(252.0 |
) |
|
$ |
1,656.8 |
|
|
$ |
484.6 |
|
|
|
|
|
Average number of common shares outstanding |
|
|
1,084.7 |
|
|
|
1,087.6 |
|
|
|
1,084.9 |
|
|
|
1,087.1 |
|
|
Contingently issuable shares |
|
|
|
|
|
|
|
|
|
|
.5 |
|
|
|
.1 |
|
|
|
|
|
Adjusted average shares |
|
|
1,084.7 |
|
|
|
1,087.6 |
|
|
|
1,085.4 |
|
|
|
1,087.2 |
|
|
|
|
|
Basic earnings (loss) per share |
|
$ |
.76 |
|
|
$ |
(.23 |
) |
|
$ |
1.53 |
|
|
$ |
.45 |
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
822.0 |
|
|
$ |
(252.0 |
) |
|
$ |
1,656.8 |
|
|
$ |
484.6 |
|
|
|
|
|
Average number of common shares outstanding |
|
|
1,084.7 |
|
|
|
1,087.6 |
|
|
|
1,084.9 |
|
|
|
1,087.1 |
|
|
Incremental shares stock options and
contingently issuable shares |
|
|
.6 |
|
|
|
|
|
|
|
1.3 |
|
|
|
2.6 |
|
|
|
|
|
Adjusted average shares |
|
|
1,085.3 |
|
|
|
1,087.6 |
|
|
|
1,086.2 |
|
|
|
1,089.7 |
|
|
|
|
|
Diluted earnings (loss) per share |
|
$ |
.76 |
|
|
$ |
(.23 |
) |
|
|
1.53 |
|
|
$ |
.44 |
|
|
|
|
exv12
EXHIBIT 12. STATEMENT RE: COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
(Unaudited)
Eli Lilly and Company and Subsidiaries
(Dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
Ended |
|
|
|
|
June 30, |
|
Years Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
2001 |
|
|
|
Consolidated pretax income
before cumulative effect of a
change in accounting principle |
|
$ |
2,097.2 |
|
|
$ |
2,717.5 |
|
|
$ |
2,941.9 |
|
|
$ |
3,261.7 |
|
|
$ |
3,457.7 |
|
|
$ |
3,506.9 |
|
|
Interest |
|
|
184.5 |
|
|
|
245.7 |
|
|
|
162.9 |
|
|
|
121.9 |
|
|
|
140.0 |
|
|
|
253.3 |
|
|
Less interest capitalized
during the period |
|
|
(53.7 |
) |
|
|
(140.5 |
) |
|
|
(111.3 |
) |
|
|
(60.9 |
) |
|
|
(60.3 |
) |
|
|
(61.5 |
) |
|
|
|
|
Earnings |
|
$ |
2,228.0 |
|
|
$ |
2,822.7 |
|
|
$ |
2,993.5 |
|
|
$ |
3,322.7 |
|
|
$ |
3,537.4 |
|
|
$ |
3,698.7 |
|
|
|
|
|
Fixed charges |
|
$ |
184.5 |
|
|
$ |
245.7 |
|
|
$ |
162.9 |
|
|
$ |
121.9 |
|
|
$ |
140.0 |
|
|
$ |
253.3 |
|
|
|
|
|
Ratio of earnings to
fixed charges |
|
|
12.1 |
|
|
|
11.5 |
|
|
|
18.4 |
|
|
|
27.3 |
|
|
|
25.3 |
|
|
|
14.6 |
|
|
|
|
exv31w1
EXHIBIT 31.1 Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the Board and
Chief Executive Officer
CERTIFICATIONS
I, Sidney Taurel, chairman of the board and chief executive officer, certify
that:
|
1. |
|
I have reviewed this report on Form 10-Q of Eli Lilly and Company; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements made,
in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report; |
|
|
4. |
|
The registrants other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or
caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the registrants internal
control over financial reporting that occurred during the registrants most
recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrants internal control over financial reporting;
and |
|
5. |
|
The registrants other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrants auditors and the audit committee of the registrants board of directors
(or persons performing the equivalent function): |
|
a) |
|
All significant deficiencies and material weaknesses in the
design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrants ability to record,
process, summarize, and report financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or
other employees who have a significant role in the registrants internal
controls over financial reporting. |
Date: August 1, 2006
|
|
|
|
|
By:
|
|
/s/ Sidney Taurel
Sidney Taurel
|
|
|
|
|
Chairman of the Board and Chief Executive Officer |
|
|
exv31w2
EXHIBIT 31.2 Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President and Chief Financial Officer
CERTIFICATIONS
I, Derica W. Rice, senior vice president and chief financial officer, certify
that:
|
1. |
|
I have reviewed this report on Form 10-Q of Eli Lilly and Company; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements made,
in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report; |
|
|
4. |
|
The registrants other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or
caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the registrants internal
control over financial reporting that occurred during the registrants most
recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrants internal control over financial reporting;
and |
|
5. |
|
The registrants other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the
registrants auditors and the audit committee of the registrants board of directors
(or persons performing the equivalent function): |
|
a) |
|
All significant deficiencies and material weaknesses in the
design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrants ability to record,
process, summarize, and report financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or
other employees who have a significant role in the registrants internal
controls over financial reporting. |
Date: August 1, 2006
|
|
|
|
|
By:
|
|
/s/ Derica W. Rice
Derica W. Rice
|
|
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
exv32
EXHIBIT 32. Section 1350 Certification
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350,
chapter 63 of title 18, United States Code), each of the undersigned officers of Eli Lilly and
Company, an Indiana corporation (the Company), does hereby certify that, to the best of their
knowledge:
The Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, (the Form 10-Q) of the
Company fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange
Act of 1934 and information contained in the Form 10-Q fairly presents, in all material respects,
the financial condition and results of operations of the Company.
|
|
|
|
|
|
|
|
Date August 1, 2006 |
/s/ Sidney Taurel
|
|
|
Sidney Taurel |
|
|
Chairman of the Board and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
Date August 1, 2006 |
/s/ Derica W. Rice
|
|
|
Derica W. Rice |
|
|
Senior Vice President and Chief Financial Officer |
|
|